FREESTYLE LIBRE 3
Report
- Report Number
- 2954323-2022-12374
- Event Type
- Injury
- Date Received
- April 15, 2022
- Date of Event
- April 5, 2022
- Report Date
- July 1, 2022
- Manufacturer
- ABBOTT DIABETES CARE LTD
- Product Code
- QLG
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DATE THE INCIDENT OCCURRED IS UNKNOWN. THE DATE ENTERED IN IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THE DEVICE MANUFACTURING DATE IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, MODEL NUMBER 72114-01, WHICH HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., MODEL NUMBER 71992-01. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DATE THE INCIDENT OCCURRED IS UNKNOWN. THE DATE ENTERED IN SECTION B3 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THE DEVICE MANUFACTURING DATE IS UNKNOWN. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, MODEL NUMBER 72114-01, WHICH HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., MODEL NUMBER 71992-01. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. THIS SERVES AS A CORRECTION REPORT: SECTION G4-PMA/510(K) # HAS BEEN CORRECTED TO N/A, AS DEVICE IN QUESTION IS NOT DISTRIBUTED IN THE U.S.
REPEATED ATTEMPTS BY ADC TO RETRIEVE THE PRODUCT WERE UNSUCCESSFUL AND/OR THE CUSTOMER DISCARDED THE PRODUCT. NO PRODUCT HAS BEEN RETURNED AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND IT HAS BEEN DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. A TRACKING AND TRENDING DATA IS NOT CURRENTLY CAPTURED BECAUSE IT IS NEWLY RELEASED PRODUCT AND DOES NOT HAVE SUFFICIENT DATA TO BE ABLE TO ESTABLISH A BASELINE COMPLAINT RATE AT THIS TIME. TYPICALLY, THE BASELINES WILL BE ESTABLISHED WITHIN 12 MONTHS FROM RELEASE IF A STABLE COMPLAINT RATE HAS BEEN REACHED. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED, AND A FOLLOW-UP REPORT SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
A CUSTOMER REPORTED A SIGNAL LOSS ISSUE WITH THE ADC DEVICE, AND WAS THEREFORE UNAWARE OF CHANGES IN GLUCOSE. THE CUSTOMER SUBSEQUENTLY BECAME UNRESPONSIVE, WAS TREMBLING, AND LOST CONSCIOUSNESS. THE CUSTOMER WAS TREATED WITH LIQUID GLUCOSE BY A THIRD-PARTY. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A CUSTOMER REPORTED A SIGNAL LOSS ISSUE WITH THE ADC DEVICE, AND WAS THEREFORE UNAWARE OF CHANGES IN GLUCOSE. THE CUSTOMER SUBSEQUENTLY BECAME UNRESPONSIVE, WAS TREMBLING, AND LOST CONSCIOUSNESS. THE CUSTOMER WAS TREATED WITH LIQUID GLUCOSE BY A THIRD-PARTY. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A CUSTOMER REPORTED A SIGNAL LOSS ISSUE WITH THE ADC DEVICE, AND WAS THEREFORE UNAWARE OF CHANGES IN GLUCOSE. THE CUSTOMER SUBSEQUENTLY BECAME UNRESPONSIVE, WAS TREMBLING, AND LOST CONSCIOUSNESS. THE CUSTOMER WAS TREATED WITH LIQUID GLUCOSE BY A THIRD-PARTY. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1907725 | FREESTYLE LIBRE 3 | CONTINUOUS GLUCOSE MONITORING SYSTEM | QLG | ABBOTT DIABETES CARE LTD | 72114-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |