FREESTYLE LIBRE 2
Report
- Report Number
- 2954323-2023-14096
- Event Type
- Injury
- Date Received
- April 10, 2023
- Date of Event
- March 14, 2023
- Report Date
- December 19, 2023
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- QLG
- PMA / PMN Number
- K210943
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
ATTEMPTED TO RECREATE THE USER COMPLAINT , USING A SIMILAR CONFIGURATION OF AN A5X PHONE AND THE FREESTYLE LIBRELINK SPECIAL EDITION APP VERSION (ANDROID 9, 21.0.0.6714). THE REPORTED ISSUE WAS UNABLE TO BE REPLICATED AND THE SYSTEM FUNCTIONED AS INTENDED, ASSUMING THE CUSTOMER HAD THE APPROPRIATE PHONE SETTINGS ENABLED, INCLUDING NOTIFICATION, SOUND, BATTERY, AND BLUETOOTH. AN "ALARMS UNAVAILABLE" MESSAGE MAY BE DISPLAYED IF THE APPROPRIATE PHONE SETTINGS ARE NOT ENABLED. THERE WERE NO ISSUES IDENTIFIED WITH THE FREESTYLE LIBRELINK SPECIAL EDITION APP DURING REPLICATION THAT WOULD HAVE LED TO THE REPORTED ISSUE AS THE CASE DID NOT STATE THAT THE APPROPRIATE PHONE SETTINGS WERE DISABLED. THEREFORE, THIS ISSUE IS NOT CONFIRMED. 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 DATE THE INCIDENT OCCURRED IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. 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.
REPEATED ATTEMPTS BY ADC TO RETRIEVE THE PRODUCT WERE UNSUCCESSFUL AND/OR THE CUSTOMER DISCARDED THE PRODUCT. THE MOST PROBABLE ROOT CAUSES ASSOCIATED WITH THIS FAILURE MODE ARE SOFTWARE/DATA CORRUPTION, OR MISUSE. HOWEVER, MITIGATIONS ARE IN PLACE TO REDUCE AND PREVENT SUCH ISSUES. ALL VITAL FUNCTIONS ARE MONITORED BY THE SYSTEM AND, WHEN NECESSARY, FUNCTION IS SUSPENDED TO SAFEGUARD AGAINST INACCURATE RESULTS. LABELING IS PROVIDED TO INSTRUCT THE USER ON THE INTENDED USE OF ALL VITAL PARTS OF THE SYSTEM TO MINIMIZE MISUSE. ALL COMPLAINTS AND COMPLAINT TRENDS ARE INVESTIGATED TO DETERMINE IF THERE IS A PRODUCT DEFECT/ DEFICIENCY. IF A PRODUCT DEFECT/ DEFICIENCY IS IDENTIFIED, A RISK EVALUATION IS COMPLETED AND COMPARED TO THE RISK MANAGEMENT REPORT, TO ENSURE THE RISK PROFILE HAS NOT CHANGED. ADDITIONALLY, AS A PART OF ABBOTT¿S POST-MARKET SURVEILLANCE PROCESS, ALL RISK EVALUATIONS WITH ASSOCIATED COMPLAINT DATA ARE REVIEWED ANNUALLY TO DETERMINE IF THE RISK PROFILES HAVE CHANGED AS COMPARED TO THE PRODUCT RISK MANAGEMENT REPORTS. THESE MONITORING PROCESSES ENSURE THAT ALL PRODUCT RISK PROFILES REMAIN ACCEPTABLE AND HAVE A POSITIVE BENEFIT/ RISK RATIO. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT. THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE DHRS (DEVICE HISTORY REVIEW) 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 ALARM ISSUE WAS REPORTED WITH THE ADC APPLICATION IN USE WITH NUU A5X, OS 9, APP VERSION 21.0.0.6714 . THE LOW AND HIGH ALARM DID NOT SOUND TO ALERT THE CUSTOMER OF CHANGES IN THEIR GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER RECEIVED THIRD PARTY MEDICAL TREATMENT HOWEVER, DETAILS OF THE TREATMENT WAS NOT PROVIDED AS NO FURTHER INFORMATION WAS PROVIDED. 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 "NUU-OS9:21006714" OPERATING SYSTEM. THE LOW AND HIGH ALARM DID NOT SOUND TO ALERT THE CUSTOMER OF CHANGES IN THEIR GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER RECEIVED THIRD PARTY MEDICAL TREATMENT HOWEVER, DETAILS OF THE TREATMENT WAS NOT PROVIDED AS NO FURTHER INFORMATION WAS PROVIDED. 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 NUU A5X, OS 9, APP VERSION 21.0.0.6714 . THE LOW AND HIGH ALARM DID NOT SOUND TO ALERT THE CUSTOMER OF CHANGES IN THEIR GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER RECEIVED THIRD PARTY MEDICAL TREATMENT HOWEVER, DETAILS OF THE TREATMENT WAS NOT PROVIDED AS NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1912202 | FREESTYLE LIBRE 2 | FLASH GLUCOSE MONITORING SYSTEM | QLG | ABBOTT DIABETES CARE INC | 71857-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |