FREESTYLE LIBRE 2
Report
- Report Number
- 2954323-2023-51022
- Event Type
- Injury
- Date Received
- November 22, 2023
- Date of Event
- November 17, 2023
- Report Date
- March 1, 2024
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- QLG
- UDI-DI
- 00357599800000
- PMA / PMN Number
- K193371
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- 003
Narratives
SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. THE SENSOR PLUG IS PROPERLY SEATED AND NO PHYSICAL DAMAGE WAS OBSERVED ON THE SENSOR PATCH. EXTRACTED DATA FROM THE RETURNED SENSOR USING APPROVED SOFTWARE. THE SENSOR WAS FOUND TO BE IN SENSOR STATE 5 (INDICATING NORMAL TERMINATION). VISUAL INSPECTION HAS BEEN PERFORMED ON THE SENSOR PLUG ASSEMBLY, NO FAILURE MODES WERE OBSERVED. SIM VIVO TESTING (SIMULATION OF THE ELECTRICAL SIGNAL PRODUCED BY THE SENSOR TAIL) AND POISE VOLTAGE TESTING WERE PERFORMED AND ALL RESULTS WERE WITHIN SPECIFICATION. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. THEREFORE, THE ISSUE IS NOT CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. THE SENSOR PLUG IS PROPERLY SEATED AND NO PHYSICAL DAMAGE WAS OBSERVED ON THE SENSOR PATCH. EXTRACTED DATA FROM THE RETURNED SENSOR USING APPROVED SOFTWARE. THE SENSOR WAS FOUND TO BE IN SENSOR STATE STATE 3 (INDICATING THE SENSOR WAS PAIRED WITHIN THE LAST 14 DAYS). VISUAL INSPECTION HAS BEEN PERFORMED ON THE SENSOR PLUG ASSEMBLY, NO FAILURE MODES WERE OBSERVED. SIM VIVO TESTING (SIMULATION OF THE ELECTRICAL SIGNAL PRODUCED BY THE SENSOR TAIL) AND POISE VOLTAGE TESTING WERE PERFORMED AND ALL RESULTS WERE WITHIN SPECIFICATION. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. THEREFORE, THE ISSUE IS NOT CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.THIS SERVES AS A CORRECTION REPORT.
THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. 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 DEVICE HISTORY RECORDS (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, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
AN ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. CUSTOMER RECEIVED A "REPLACE SENSOR" MESSAGE AND WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING THIRD-PARTY TREATMENT OF "BAQSIMI® (GLUCAGON) NASAL POWDER" (DOSE UNSPECIFIED), URSODIOL (DOSE UNSPECIFIED), IMURAN (DOSE UNSPECIFIED), MELOXICAM (DOSE UNSPECIFIED), AND LITHIUM (DOES UNSPECIFIED) BY A NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
AN ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. CUSTOMER RECEIVED A "REPLACE SENSOR" MESSAGE AND WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING THIRD-PARTY TREATMENT OF "BAQSIMI® (GLUCAGON) NASAL POWDER" (DOSE UNSPECIFIED), URSODIOL (DOSE UNSPECIFIED), IMURAN (DOSE UNSPECIFIED), MELOXICAM (DOSE UNSPECIFIED), AND LITHIUM (DOES UNSPECIFIED) BY A NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
AN ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. CUSTOMER RECEIVED A "REPLACE SENSOR" MESSAGE AND WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING THIRD-PARTY TREATMENT OF "BAQSIMI® (GLUCAGON) NASAL POWDER" (DOSE UNSPECIFIED), URSODIOL (DOSE UNSPECIFIED), IMURAN (DOSE UNSPECIFIED), MELOXICAM (DOSE UNSPECIFIED), AND LITHIUM (DOES UNSPECIFIED) BY A NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 722500 | FREESTYLE LIBRE 2 | FLASH GLUCOSE MONITORING SYSTEM | QLG | ABBOTT DIABETES CARE INC | 71992-01 | 00357599800000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Male | Required Intervention |