FREESTYLE LIBRE 2
Report
- Report Number
- 2954323-2021-90288
- Event Type
- Injury
- Date Received
- October 27, 2021
- Date of Event
- September 30, 2021
- Report Date
- January 10, 2023
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- QLG
- PMA / PMN Number
- K193371
- Adverse Event
- 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. NO PRODUCT HAS BEEN RETURNED. 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 SPECIFICATIONS. DOSE AUDIT REPORTS WERE REVIEWED AND DEMONSTRATED THE CONTINUED EFFECTIVENESS OF THE ESTABLISHED STERILIZATION PROCESS FOR LIBRE SENSOR KITS. ENVIRONMENTAL MONITORING REPORTS WERE REVIEWED, INCLUDING BIOBURDEN AND ENDOTOXIN TESTING, AND DEMONSTRATED THAT ALL MONITORING PROCESSES CONTINUE TO MEET ADC REQUIREMENTS. DHRS FOR THE FS LIBRE SENSOR AND FS LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FS LIBRE SENSOR AND SENSOR KIT 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 AS H10 IN THE PREVIOUS INITIAL MDR REPORT INADVERTENTLY DID NOT INCLUDE THE EXTENDED INVESTIGATION. H10 AND H6 HAVE BEEN UPDATED.
THIS SERVES AS A CORRECTION REPORT. EMDR-241288 INADVERTENTLY DID NOT INCLUDE THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES IN (H6 - ADVERSE EVENT PROBLEM). H6 HAS BEEN UPDATED TO REFLECT THE INVESTIGATION CODES AT THAT TIME.
SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION HAS BEEN PERFORMED NO ISSUES WERE OBSERVED ON SENSOR PATCH. THEREFORE, ISSUE IS NOT CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
CUSTOMER REPORTED EXPERIENCING A SKIN REACTION WHILE WEARING AN ADC FREESTYLE LIBRE 2 SENSOR AND REPORTED OBSERVING INFLAMMATION AND "INFECTION AND THICKENING UNDER THE SENSOR" UPON SENSOR REMOVAL. CUSTOMER HAD CONTACT WITH A FAMILY DOCTOR AND WAS PRESCRIBED AN UNSPECIFIED OINTMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
CUSTOMER REPORTED EXPERIENCING A SKIN REACTION WHILE WEARING AN ADC FREESTYLE LIBRE 2 SENSOR AND REPORTED OBSERVING INFLAMMATION AND "INFECTION AND THICKENING UNDER THE SENSOR" UPON SENSOR REMOVAL. CUSTOMER HAD CONTACT WITH A FAMILY DOCTOR AND WAS PRESCRIBED AN UNSPECIFIED OINTMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
CUSTOMER REPORTED EXPERIENCING A SKIN REACTION WHILE WEARING AN ADC FREESTYLE LIBRE 2 SENSOR AND REPORTED OBSERVING INFLAMMATION AND "INFECTION AND THICKENING UNDER THE SENSOR" UPON SENSOR REMOVAL. CUSTOMER HAD CONTACT WITH A FAMILY DOCTOR AND WAS PRESCRIBED AN UNSPECIFIED OINTMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
CUSTOMER REPORTED EXPERIENCING A SKIN REACTION WHILE WEARING AN ADC FREESTYLE LIBRE 2 SENSOR AND REPORTED OBSERVING INFLAMMATION AND "INFECTION AND THICKENING UNDER THE SENSOR" UPON SENSOR REMOVAL. CUSTOMER HAD CONTACT WITH A FAMILY DOCTOR AND WAS PRESCRIBED AN UNSPECIFIED OINTMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1605518 | FREESTYLE LIBRE 2 | FLASH GLUCOSE MONITORING SYSTEM | QLG | ABBOTT DIABETES CARE INC | 71992-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |