LIBRE 3 SENSOR FREESTYLE
Report
- Report Number
- 2954323-2022-05506
- Event Type
- Malfunction
- Date Received
- February 17, 2022
- Date of Event
- January 31, 2022
- Report Date
- April 20, 2022
- Manufacturer
- ABBOTT DIABETES CARE LTD
- Product Code
- QLG
- PMA / PMN Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
REPEATED ATTEMPTS BY ADC TO RETRIEVE THE PRODUCT WERE UNSUCCESSFUL AND/OR THE CUSTOMER DISCARDED THE PRODUCT. AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. SENSOR KIT EXPIRATION DATE IS 30-NOV-21. CASE AWARENESS DATE IS (B)(6) 2022, WHICH CONFIRMS DEVICE IS BEYOND THE USEFUL LIFE. ADDITIONAL INVESTIGATION ACTIVITIES ARE NOT REQUIRED AS THE DEVICE MET SPECIFICATION WHEN IT WAS RELEASED AND THROUGHOUT ITS LIFESPAN. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. 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. AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. SENSOR KIT EXPIRATION DATE IS 30-NOV-21. CASE AWARENESS DATE IS (B)(6) 2022, WHICH CONFIRMS DEVICE IS BEYOND THE USEFUL LIFE. ADDITIONAL INVESTIGATION ACTIVITIES ARE NOT REQUIRED AS THE DEVICE MET SPECIFICATION WHEN IT WAS RELEASED AND THROUGHOUT ITS LIFESPAN. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. 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.
SENSOR (B)(6) WAS RETURNED AND INVESTIGATED. VISUAL INSPECTION WAS PERFORMED ON THE RETURNED SENSOR, NO ISSUES WERE OBSERVED. DATA WAS EXTRACTED USING APPROVED SOFTWARE, AND EXTRACTION WAS SUCCESSFUL. EXTENDED INVESTIGATION WAS PERFORMED, AND VISUAL INSPECTION OBSERVED MINOR DAMAGE TO THE SENSOR TAIL. THIS DAMAGE WAS DETERMINED TO HAVE OCCURRED IN TRANSIT AND NO OTHER ISSUES WERE OBSERVED. THE SENSOR WAS THEN DE-CASED AND INSPECTED. VISUAL INSPECTION OF THE SENSOR COMPONENTS AND SENSOR TAIL FLAG WERE CHECKED AND NO ISSUES WERE OBSERVED. A GLUCOSE TEST WAS PERFORMED ON THE SENSOR WITH A KNOWN GOOD READER AND NO ABNORMALITIES OR DEFECTS WERE OBSERVED. THEREFORE THIS ISSUE IS NOT CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO EITHER THE C, D, OR E ZONE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO EITHER THE C, D, OR E ZONE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO EITHER THE C, D, OR E ZONE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 860862 | LIBRE 3 SENSOR FREESTYLE | CONTINUOUS GLUCOSE MONITORING SYSTEM | QLG | ABBOTT DIABETES CARE LTD | 72114-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |