FREESTYLE LIBRE 2
Report
- Report Number
- 2954323-2023-01332
- Event Type
- Injury
- Date Received
- January 9, 2023
- Date of Event
- December 12, 2022
- Report Date
- April 26, 2023
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- QLG
- PMA / PMN Number
- K210943
- Removal / Correction Number
- QUALITY RECORD QR869957
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- 003
Narratives
AT THIS TIME PRODUCT HAS NOT YET 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 SPECIFICATION. THE DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE SENSOR AND LIBRE SENSOR KITS WERE REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR AND LIBRE SENSOR KITS PASSED ALL TESTS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
ADC HAS IDENTIFIED A SOFTWARE DEFECT FOR THE FREESTYLE LIBRE 2 APPLICATION A (SAMSUNG S22+ 2.8.2.9318) PHONE WITH THE ANDROID 13 OS WHERE THE APPLICATION MAY EXPERIENCE INTERMITTENT SIGNAL LOSS. AS A RESULT, THE APPLICATION USER MAY NOT RECEIVE GLUCOSE RESULTS AND/OR GLUCOSE ALARMS AND MAY NOT BE ALERTED OF LOW OR HIGH GLUCOSE CONDITIONS. BASED ON THE INVESTIGATION, THIS COMPLAINT IS CONFIRMED. THIS ISSUE WAS ADDRESSED IN THE FIELD BY ADC FA1010-2023. 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. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. 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. SUCCESSFULLY RECEIVED HIGH/LOW GLUCOSE ALARMS ON IOS AND ANDROID. NO ISSUES WERE IDENTIFIED WITH FREESTYLE LIBRE 2 APPLICATION. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. THIS SERVES AS A CORRECTION REPORT. SECTION H10(ADDTL MFG NARRATIVE) WAS INCORRECTLY DOCUMENTED IN THE PREVIOUS REPORT. CORRECTION HAS BEEN MADE.
A CUSTOMER REPORTED AN ALARM ISSUE WITH THE ADC DEVICE. THE CUSTOMER EXPERIENCED SWEATING AND DISCOMFORT AND WAS GIVEN SUGAR-WATER BY A THIRD-PARTY FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
AN ALARM ISSUE WAS REPORTED WITH THE ADC APPLICATION IN USE WITH A (SAMSUNG S22+ 2.8.2.9318) WITH ANDROID 13 OPERATING SYSTEM. THE LOW AND HIGH GLUCOSE ALARMS DID NOT SOUND AND CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED SWEATING AND DISCOMFORT AND WAS GIVEN SUGAR-WATER BY A THIRD-PARTY FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT. THE IMPACTED PRODUCT ASSOCIATED WITH THIS COMPLAINT IS ON MARKET IN THE UNITED STATES AS WELL AS THE FOLLOWING COUNTRIES OUS: AU, AT, BE, HR, CZ, DK, FI, FR, DE, GR, IL, IT, KW, LU, NL, NZ, NO, PL, PT, QA, SA, ES, SE, CH, TW, AE, GB, CA. FIELD ACTION FA1010-2023 WAS ISSUED TO ALL IMPACTED COUNTRIES 08FEB23.
A CUSTOMER REPORTED AN ALARM ISSUE WITH THE ADC DEVICE. THE CUSTOMER EXPERIENCED SWEATING AND DISCOMFORT AND WAS GIVEN SUGAR-WATER BY A THIRD-PARTY FOR 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 |
|---|---|---|---|---|---|---|---|
| 2304515 | FREESTYLE LIBRE 2 | FLASH GLUCOSE MONITORING SYSTEM | QLG | ABBOTT DIABETES CARE INC | 71857-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |