FREESTYLE LIBRE 3
Report
- Report Number
- 2954323-2022-05595
- Event Type
- Injury
- Date Received
- February 17, 2022
- Date of Event
- February 4, 2022
- Report Date
- March 30, 2022
- Manufacturer
- ABBOTT DIABETES CARE LTD
- Product Code
- QLG
- 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 DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IN 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 DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IN 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.
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. SHELF LIFE AND CLINICAL DATA WAS REVIEWED DURING PRODUCT DEVELOPMENT AND MARKET PERFORMANCE CONTINUES TO BE MONITORED VIA CLINICAL TRIALS AS A PART OF ON MARKET PERFORMANCE MONITORING PROCESS. A TRIPPED TREND REVIEW WAS NOT CONDUCTED FOR THE REPORTED COMPLAINT AND FS LIBRE SENSOR. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORM AND A FOLLOW-UP REPORT SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.UPON EXTENDED INVESTIGATION, IT WAS DETERMINED THAT THE SERIAL NUMBER PROVIDED BY THE CUSTOMER ((B)(6) ) AND PREVIOUSLY REPORTED TO THE FDA WAS NOT A VALID SERIAL NUMBER. THEREFORE, SECTION D4 WAS UPDATED TO UNK.
A SIGNAL LOSS WAS REPORTED WITH THE FREESTYLE LIBRE 3 SENSOR IN USE WITH THE FREESTYLE LIBRELINK APPLICATION AND CUSTOMER WAS UNABLE TO RECEIVE HIGH AND LOW GLUCOSE ALARMS. AS A RESULT, CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING TREATMENT OF ORAL GLUCOSE ADMINISTERED BY THIRD-PARTY. CUSTOMER HAD CONTACT WITH AN HCP WHO OBTAINED A READING OF 59 MG/DL, HOWEVER IT IS UNKNOWN WHEN THIS READING WAS OBTAINED IN RELATION TO THE REPORTED TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A SIGNAL LOSS WAS REPORTED WITH THE FREESTYLE LIBRE 3 SENSOR IN USE WITH THE FREESTYLE LIBRELINK APPLICATION AND CUSTOMER WAS UNABLE TO RECEIVE HIGH AND LOW GLUCOSE ALARMS. AS A RESULT, CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING TREATMENT OF ORAL GLUCOSE ADMINISTERED BY THIRD-PARTY. CUSTOMER HAD CONTACT WITH AN HCP WHO OBTAINED A READING OF 59 MG/DL, HOWEVER IT IS UNKNOWN WHEN THIS READING WAS OBTAINED IN RELATION TO THE REPORTED TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A SIGNAL LOSS WAS REPORTED WITH THE FREESTYLE LIBRE 3 SENSOR IN USE WITH THE FREESTYLE LIBRELINK APPLICATION AND CUSTOMER WAS UNABLE TO RECEIVE HIGH AND LOW GLUCOSE ALARMS. AS A RESULT, CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING TREATMENT OF ORAL GLUCOSE ADMINISTERED BY THIRD-PARTY. CUSTOMER HAD CONTACT WITH AN HCP WHO OBTAINED A READING OF 59 MG/DL, HOWEVER IT IS UNKNOWN WHEN THIS READING WAS OBTAINED IN RELATION TO THE REPORTED TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2952 | FREESTYLE LIBRE 3 | CONTINUOUS GLUCOSE MONITORING SYSTEM | QLG | ABBOTT DIABETES CARE LTD | 72114-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |