FREESTYLE LIBRE 3
Report
- Report Number
- 2954323-2022-06436
- Event Type
- Injury
- Date Received
- February 24, 2022
- Date of Event
- February 16, 2022
- Report Date
- April 11, 2022
- Manufacturer
- ABBOTT DIABETES CARE LTD
- Product Code
- NBW
- PMA / PMN Number
- VERIFY
- 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 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 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. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED ON THE REPORTED COMPLAINT AND IT HAS BEEN DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET THE SPECIFICATIONS. DHRS FOR THE LIBRE SENSOR AND SENSOR KIT INDICATED WERE REVIEWED AND NO NONCONFORMITIES WERE FOUND THAT WOULD HAVE AN IMPACT ON PRODUCT PERFORMANCE. THE DHRS SHOWED THE LIBRE SENSOR AND SENSOR KITS PASSED ALL TESTS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, THE CASE WILL BE RE-OPENED, AND A PHYSICAL INVESTIGATION WILL BE PERFORMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
THIS SERVES AS A CORRECTION REPORT. SECTION D1 WAS INCORRECTLY DOCUMENTED IN THE PREVIOUS INITIAL MDR REPORT. THIS SECTION HAVE BEEN UPDATED.
A SIGNAL LOSS ISSUE WAS REPORTED WITH THE FREESTYLE LIBRE 3 SENSOR. A CUSTOMER REPORTED A SENSOR SIGNAL LOSS AND AS RESULT, EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER WAS PROVIDED 2 COOKIES BY A THIRD PARTY AS TREATMENT AND NO FURTHER INFORMATION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A SIGNAL LOSS ISSUE WAS REPORTED WITH THE FREESTYLE LIBRE 3 SENSOR. A CUSTOMER REPORTED A SENSOR SIGNAL LOSS AND AS RESULT, EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER WAS PROVIDED 2 COOKIES BY A THIRD PARTY AS TREATMENT AND NO FURTHER INFORMATION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A SIGNAL LOSS ISSUE WAS REPORTED WITH THE FREESTYLE LIBRE 3 SENSOR. A CUSTOMER REPORTED A SENSOR SIGNAL LOSS AND AS RESULT, EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER WAS PROVIDED 2 COOKIES BY A THIRD PARTY AS TREATMENT AND NO FURTHER INFORMATION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A SIGNAL LOSS ISSUE WAS REPORTED WITH THE FREESTYLE LIBRE 3 SENSOR. A CUSTOMER REPORTED A SENSOR SIGNAL LOSS AND AS RESULT, EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER WAS PROVIDED 2 COOKIES BY A THIRD PARTY AS TREATMENT AND NO FURTHER INFORMATION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1864142 | FREESTYLE LIBRE 3 | FLASH GLUCOSE MONITORING SYSTEM | NBW | ABBOTT DIABETES CARE LTD | 72114-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |