UPPKOMNA PROBLEM MED CGM SENSORER
• Dagens Medicin 251128
Felaktiga glukossensorer kopplas till sju dödsfall world wide
Ett företag som tillhandahåller medicintekniska produkter varnar för defekta sensorer som kan visa felaktiga blodsockernivåer. Defekterna misstänks ha bidragit till dödsfall.
”Att ha för hög tilltro till teknik kan vara farligt i sig”, säger Helena Henriksson på Läkemedelsverket
”Om det inte upptäcks kan felaktigt låga glukosvärden under en längre tid leda till felaktiga behandlingsbeslut för personer som lever med diabetes, såsom överdrivet intag av kolhydrater eller att insulindoser inte ges
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• Patienter med diabetes fick livshotande blodsocker – sensor visade fel 250918
SR P4
En specialistsjuksköterska i Västerås har anmält en glukossensor till Läkemedelsverket efter att den visat felaktigt låga värden för en patient med typ ett-diabetes.Sensorns felaktiga värden ledde till att patienten åt kolhydrater och socker.
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• Reuters Health Nov 24
https://www.reuters.com/business/healthcare-pharmaceuticals/abbott-issues-us-device-correction-some-glucose-monitors-over-faulty-readings-2025-11-24
Abbott issues US device correction for some glucose monitors over faulty readings risk
Abbott said on Monday it has begun a correction in the United States for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose monitoring sensors after internal testing showed some units may report falsely low glucose readings.
About 3 million sensors are affected in the U.S., roughly half of which are estimated to have expired or already been used, the company said.
Abbott has received 736 reports globally of severe adverse events and seven deaths world wide that may be linked to the issue. None of the deaths occurred in the U.S.
The problem, tied to one production line, could lead to incorrect treatment decisions for people with diabetes, including excessive carbohydrate intake or missed insulin doses, posing serious health risks, the company said.
A correction is an action to address a problem with a product already on the market or in use without physically removing it from circulation.
Abbott said it has resolved the manufacturing issue and continues to produce sensors to meet replacement and new orders without significant supply disruptions.
Users can check if their sensors are affected and request free replacements at www.freestylecheck.com.
The company advised users to stop using any confirmed affected sensors immediately and to rely on a blood glucose meter for treatment decisions when sensor readings do not match symptoms.
Other Libre products, readers and apps are not affected, and the correction is also being implemented in other countries where Libre 3 and Libre 3 Plus sensors are sold, Abbott said.
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• US Food and Drug, FDA
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/continuous-glucose-monitoring-cgm-sensor-recall-abbott-diabetes-care-inc-issues-recall-certain
Continuous Glucose Monitoring (CGM) Sensor Recall:
Abbott Diabetes Care Inc Issues Recall for Certain FreeStyle Libre 3 Sensors due to Risk for Inaccurate High Glucose Readings
This recall involves removing certain devices from where they are used or sold, and does not apply to the FreeStyle Libre 3 reader or app.
The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
Image of the app screen, reader settings, sensor applicator label, and sensor carton
- Product Name: FreeStyle Libre 3 sensor, a component of FreeStyle Libre 3 Continuous Glucose Monitoring System
- Unique Device Identifier (UDI)/Model: UDI-DI 00357599818005/ Model No 72081-01
- Lot Numbers:
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- T60001948
- T60001966
- T60001969
What to Do
- Users of FreeStyle Libre 3 sensors should follow the instructions below to check the sensor serial numbers to find out if the sensor is in the affected lot.
- Distributors of FreeStyle Libre 3 sensors should check their inventory to find out if there are any affected sensors left in their inventory.
- Immediately stop using and distributing any affected sensors.
- Throw affected sensors away.
On July 24, 2024, Abbott Diabetes Care Inc sent all affected customers an Urgent Medical Device Recall recommending the following actions:
- Immediately discontinue use and dispose of any affected sensors.
- Request a replacement for any affected sensor(s) by visiting https://www.freestyleconfirm.com/us-en/home.htmlExternal Link Disclaimer.
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- Select “CONFIRM SENSOR SERIAL NUMBER” and enter a valid serial number.
- Customers with impacted sensors will be instructed to enter contact information so a replacement product can be sent at no cost.
- If there are symptoms that do not match the sensor glucose reading or it is suspected that a glucose reading is inaccurate, check the reading by conducting a fingerstick test using any blood glucose meter.
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- The built-in blood glucose meter in the FreeStyle Libre 3 Reader is not affected by this recall and may be used to check glucose at any time.
Reason for Recall
Abbott Diabetes Care Inc is recalling these FreeStyle Libre 3 sensors after finding that a small number of FreeStyle Libre 3 sensors may provide incorrect high glucose readings, which if undetected may pose a potential health risk for people living with diabetes.
The use of affected product may cause serious adverse health consequences, including severe low blood sugar (hypoglycemia) which can cause central nervous system problems, loss of consciousness, seizures, coma, permanent brain damage, and death.
There have been 2 reported injuries. There have been no reports of death.
Device Use
The FreeStyle Libre 3 Continuous Glucose Monitoring System is intended to provide continuous monitoring of glucose levels. It helps people manage diabetes by detecting trends and tracking patterns in glucose levels so treatment can be adjusted as needed. It is indicated for single patient use, and requires a prescription.
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• www.diatribe.org 251201
FreeStyle Libre 3 CGM Users Notified of Dangerous False Low Alerts
Abbott issued an urgent correction for FreeStyle Libre 3 and Libre 3 Plus sensors after more than 700 adverse events – including seven deaths world wide – were reported due to issues with sensors providing incorrect low glucose readings.
Users of FreeStyle Libre 3 and Libre 3 Plus CGMs are urged to check their sensors here – replacements for affected sensors will be issued free of charge. The correction involves roughly 3 million sensors, half of which Abbott estimates are expired or have been used. The company issued a statement saying the issue has been identified and resolved.
The sensor’s serial number can be found on the applicator label and on the bottom of the carton. It can also be located in the FreeStyle Libre 3 reader or app.
Incorrect blood sugar readings from continuous glucose monitors can lead to the wrong treatment decisions for people with diabetes, such as skipping insulin doses or excessive carb intake. This can result in life-threatening situations, including severe diabetic ketoacidosis.
Last July, Abbott alerted FreeStyle Libre 3 users that a small number of sensors could display false high glucose readings.
This might lead people to see an incorrect high blood sugar reading and take insulin unnecessarily – a potentially dangerous situation for hpoglycemia.
.
If you have symptoms that do not match the sensor glucose reading or suspect your reading may be inaccurate,
double-check by conducting a fingerstick test using any blood glucose meter.
The built-in blood glucose meter in the FreeStyle Libre 3 reader can also be used to check your glucose.
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• Läkemedelsverket 250922
https://www.lakemedelsverket.se/sv/nyheter/freestyle-libre-3-plus-sensorer—abbott-diabetes-care-ltd
Säkerhetsmeddelande till marknaden från tillverkare.
Produkt: FreeStyle Libre 3 Plus-sensorer
Tillverkare: Abbott Diabetes Care Ltd
Tillverkarens referensnummer: ADC FA1001-2025
Läkemedelsverkets referensnummer: 6.6.2-2025-075082
Sammanfattning: Produkter ska tas ur bruk.
Läs mer inkl sälerhetsmeddelande till vården
https://www.lakemedelsverket.se/globalassets/dokument/medicinteknik/sakerhetsinformation-fran-tillverkare/2025-075082-abbott-diabetes-care-ltd-fsn-vardgivare.pdf
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Läs gärna mer om säker medicinteknik på nedan www
Insulinpump-behandling kan bli säkrare. Lex Maria. IVO.
Nynetsinfo
www red DiabetologNytt