LIBRELINK
Report
- Report Number
- 2954323-2025-46377
- Event Type
- Injury
- Date Received
- November 27, 2025
- Date of Event
- November 14, 2025
- Report Date
- December 31, 2025
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- PZE
- UDI-DI
- 00357599000059
- PMA / PMN Number
- P160030
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- 003
Narratives
THE USER REPORTED MISSING ALARMS AND NOTIFICATIONS. THE REPORTED ISSUE WAS INVESTIGATED . THE REPORTED CONFIGURATION WAS NOT COMPATIBLE WITH THE CUSTOMER'S REPORTED APPLICATION. THE COMPATIBILITY GUIDE IS AVAILABLE TO THE CUSTOMER ON THE PRODUCT'S WEBSITE. AS THE COMPATIBILITY GUIDE WAS PROVIDED TO THE CUSTOMER AND THE INCOMPATIBLE CONFIGURATIONS WERE USED, THIS COMPLAINT IS NOT CONFIRMED TO USE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
INVESTIGATION IS PENDING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DEVICE MANUFACTURING DATE DOES NOT APPLY. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. SECTION D. SUSPECTED MEDICAL DEVICE AND G4 - PMA/510(K)# HAS BEEN POPULATED FOR THE FREESTYLE LIBRELINK IOS APPLICATION AS THIS REPORT CONCERNS A NETHERLANDS CUSTOMER. THIS IS SAME/SIMILAR TO US FREESTYLE LIBRE 2 IOS APPLICATION, MODEL NUMBER 71926-01. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
AN "INCOMPATIBLE OS OR INCOMPATIBLE DEVICE" ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) IN USE WITH AN IPHONE 15, IOS OPERATING SYSTEM VERSION 18.6.2, AND APPLICATION VERSION 2.12.2.8979. THE CUSTOMER REPORTED THAT THEIR APP HAD A "SIGNAL LOSS" WITH THE SENSOR THEREFORE, THE CUSTOMER WAS NOT ALERTED OF CHANGES IN THEIR GLUCOSE LEVELS. THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER'S BLOOD GLUCOSE WAS MEASURED AND THEY WERE GIVEN GLUCOSE INFUSION BY A HEALTHCARE PROFESSIONAL FOR A DIAGNOSIS OF HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
AN "INCOMPATIBLE OS OR INCOMPATIBLE DEVICE" ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) IN USE WITH AN IPHONE 15, IOS OPERATING SYSTEM VERSION 18.6.2, AND APPLICATION VERSION 2.12.2.8979. THE CUSTOMER REPORTED THAT THEIR APP HAD A "SIGNAL LOSS" WITH THE SENSOR THEREFORE, THE CUSTOMER WAS NOT ALERTED OF CHANGES IN THEIR GLUCOSE LEVELS. THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER'S BLOOD GLUCOSE WAS MEASURED AND THEY WERE GIVEN GLUCOSE INFUSION BY A HEALTHCARE PROFESSIONAL FOR A DIAGNOSIS OF HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1891820 | LIBRELINK | DATA MANAGEMENT SYSTEM | PZE | ABBOTT DIABETES CARE INC | 71733-01 | 00357599000059 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |