BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2

    MDR report key: 10788591 · Received November 4, 2020

    Report

    Report Number
    2954323-2020-09822
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    October 28, 2020
    Report Date
    March 22, 2021
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    PMA / PMN Number
    K193371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    READER (B)(6) HAS BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION HAS BEEN PERFORMED ON THE RETURNED READER, AND NO ISSUES WERE OBSERVED. THE READER DID NOT TURN ON WITH BUTTON, STRIP, OR USB CABLE INSERTION. THE RETURNED READER WAS CONNECTED TO THE COMPUTER AND THE READER WAS NOT RECOGNIZED. THE READER WAS SENT FOR FURTHER INVESTIGATION AND DE-CASED. UPON INSPECTION THE READERS BATTERY WAS OBSERVED LEAKING. AN EXTENDED INVESTIGATION HAS ALSO BEEN PERFORMED FOR THE REPORTED COMPLAINT. ADC PRODUCT QUALITY ENGINEERING (PQE) PERFORMED, FURTHER TESTING ON THE RETURNED READER TO ENSURE THE CORRECT FUNCTIONALITY IN BATTERY MANAGEMENT. PQE MONITORED THE CHARGING CURRENT OF THE KNOWN GOOD BATTERY IN THE RETURNED READER, AND OBSERVED, IT TO INSIDE THE ACCEPTABLE LIMIT. PQE DIRECTED A HEAT SOURCE AT THE BATTERY AND OBSERVED, THE CHARGING CURRENT TO REDUCE AS THE BATTERY WARMED. AFTER THE HEAT SOURCE WAS REMOVED, THE CHARGING CURRENT WAS OBSERVED TO RECOVER. THIS INDICATES, THAT THE RETURNED READERS BATTERY TEMPERATURE MONITORING CIRCUIT IS FUNCTIONING CORRECTLY. PQE DISCONNECTED THE CHARGER AND MONITORED THE OFF CURRENT, AND OBSERVED IT TO BE INSIDE THE ACCEPTABLE LIMITS. THE ON CURRENT WAS MEASURED AND INDICATED, THE CHARGED BATTERY SENSING CIRCUIT WAS FUNCTIONING CORRECTLY. ALL THE RESULTS INDICATE, THAT THE RETURNED READERS BATTERY MANAGEMENT CIRCUITRY IS FUNCTIONING CORRECTLY. THE USAGE LOG WAS DOWNLOADED. AND THE READER HAD 0 SENSOR PAIRS AND 0 SCANS SHOWING, THIS IS AN OUT THE BOX FAILURE. THEREFORE, THIS ISSUE IS CONFIRMED, DUE TO FAULTY BATTERY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. ADVERSE EVENT PROBLEM: 4316 APPROPRIATE TERM/CODE NOT AVAILABLE WAS SELECTED. AS THE ISSUE IS CONFIRMED, DUE TO FAULTY BATTERY.

    Description of Event or Problem · 0

    CUSTOMER REPORTED. HER FREESTYLE LIBRE 2 READER WAS RECEIVED DAMAGED. AND WOULD NOT POWER ON. AS A RESULT, CUSTOMER WAS INCAPABLE OF TESTING. AND EXPERIENCED AN "ARM SEIZURE". AND REQUIRED TESTING OF GLUCOSE BY A THIRD-PARTY. CUSTOMER WAS TREATED WITH DEXTROSE AND INSULIN (DOSE/TYPE UNKNOWN) BY THE THIRD-PARTY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    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 READER WERE REVIEWED AND THE DHRS SHOWED THE LIBRE READER 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HER FREESTYLE LIBRE 2 READER WAS RECEIVED DAMAGED AND WOULD NOT POWER ON. AS A RESULT, CUSTOMER WAS INCAPABLE OF TESTING AND EXPERIENCED AN "ARM SEIZURE" AND REQUIRED TESTING OF GLUCOSE BY A THIRD-PARTY. CUSTOMER WAS TREATED WITH DEXTROSE AND INSULIN (DOSE/TYPE UNKNOWN) BY THE THIRD-PARTY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250073 FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71953-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention