FREESTYLE LIBRE 3
Report
- Report Number
- 2954323-2026-32672
- Event Type
- Malfunction
- Date Received
- April 16, 2026
- Date of Event
- March 2, 2026
- Report Date
- May 27, 2026
- Manufacturer
- ABBOTT DIABETES CARE LTD
- Product Code
- QBJ
- UDI-DI
- 05021791002689
- PMA / PMN Number
- K223435
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
THE RETURNED METER WAS INVESTIGATED. VISUAL INSPECTION WAS PERFORMED ON RETURNED METER. A MAJOR DAMAGED USB PORT WAS OBSERVED AND ALSO MELTED PORT ENTRANCE AND MELTED PLASTIC FROM THE USB PINS WERE OBSERVED. THE DAMAGED USB PORT WOULD PREVENT THE CUSTOMER FROM CHARGING THE READER WHICH WOULD LEAD TO THE READER NOT TURNING ON. AN EXTENDED INVESTIGATION WAS PERFORMED. PQE PERFORMED A VISUAL INSPECTION ON THE RETURNED READER AND OBSERVED MAJOR USB DAMAGE. IT WAS OBSERVED THAT ONE OF THE PINS TO HAVE BURN RELATED DAMAGE. READER DID NOT TURN ON WITH BUTTON. PQE DE-CASED THE RETURNED READER AND OBSERVED NO BURN MARKS TO THE PCBA, BATTERY OR ANY OTHER INTERNAL COMPONENT. PQE WAS DOWNLOADED THE READER'S LOG, CHECKED FOR CYBERSECURITY ERROR CODES, AND SAVED. PQE WAS DOWNLOADED READER USAGE LOG AND OBSERVED READING, THIS SHOWS IT WAS NOT AN OUT OF BOX FAILURE. THE RETURNED BATTERY WAS TOO LOW TO TURN ON READER, PQE USED A KNOWN GOOD BATTERY TO CONTINUE TESTING. READER TURNED ON WITH KNOWN GOOD BATTERY AND PASSED READER IN-BUILT SELF-TEST. PQE USED THERMAL CAMERA TO INSPECT FOR ANY HOTSPOT AND OBSERVED NO HOTSPOT. THE MAJOR USB DAMAGE WOULD STOP THE READER FROM CHARGING AND BEING ABLE TO TURN IT. THE LACK OF ANY BURN RELATED DAMAGE INTERNALLY ALSO SUGGEST THAT THE DAMAGE WAS CAUSED DUE TO A SHORT CAUSED BY THE USB DAMAGE WHEN PLACED ON TO CHARGE WITH A CABLE. THEREFORE, ISSUE WILL BE CLOSED TO NOT CONFIRMED TO USE DUE TO USB DAMAGE. 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. DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE READER, CABLE AND ADAPTER WAS REVIEWED AND THE DHRS SHOWED THE LIBRE READER, CABLE AND ADAPTER MET SPECIFICATIONS PRIOR TO RELEASE TO DISTRIBUTION. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
THE REPORTED PRODUCT HAS BEEN RETURNED AND IS CURRENTLY UNDERGOING INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION ACTIVITIES OR IF ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
CUSTOMER INITIALLY REPORTED THAT THEIR ABBOTT DIABETES CARE DEVICE DID NOT POWER ON. THE PRODUCT WAS RETURNED AND INVESTIGATED FOR THE POWER ISSUE, HOWEVER DURING INVESTIGATION INTERNAL BURN MARKS WERE OBSERVED. THIS REPORT IS BEING SUBMITTED DUE TO THE ADDITIONAL ISSUE OBSERVED DURING RETURNED PRODUCT INVESTIGATION. THERE NO WAS NO REPORT OF FIRE, SMOKE, EXPLOSION OR SHOCK. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
CUSTOMER INITIALLY REPORTED THAT THEIR ABBOTT DIABETES CARE DEVICE DID NOT POWER ON. THE PRODUCT WAS RETURNED AND INVESTIGATED FOR THE POWER ISSUE, HOWEVER DURING INVESTIGATION INTERNAL BURN MARKS WERE OBSERVED. THIS REPORT IS BEING SUBMITTED DUE TO THE ADDITIONAL ISSUE OBSERVED DURING RETURNED PRODUCT INVESTIGATION. THERE NO WAS NO REPORT OF FIRE, SMOKE, EXPLOSION OR SHOCK. 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 |
|---|---|---|---|---|---|---|---|
| 506756 | FREESTYLE LIBRE 3 | CONTINUOUS GLUCOSE MONITORING SYSTEM | QBJ | ABBOTT DIABETES CARE LTD | 72079-01 | 05021791002689 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |