BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBRE 2 SENSOR FREESTYLE

    MDR report key: 15189194 · Received August 8, 2022

    Report

    Report Number
    2954323-2022-27933
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    August 4, 2022
    Report Date
    December 22, 2022
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    PMA / PMN Number
    K193371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPEATED ATTEMPTS BY ADC TO RETRIEVE THE PRODUCT WERE UNSUCCESSFUL AND/OR THE CUSTOMER DISCARDED THE PRODUCT. AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. AN 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. 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.

    Additional Manufacturer Narrative · 0

    SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. THE SENSOR PLUG WAS FULLY SEATED AND NO ISSUES WERE OBSERVED. EXTRACTED DATA FROM THE RETURNED SENSOR USING APPROVED SOFTWARE. THE SENSOR WAS FOUND TO BE IN SENSOR STATE 5 (INDICATING NORMAL TERMINATION). THE DEBRIS OBSERVED IS MOST LIKELY THE AFTERMATH OF THE SENSOR PLUG BEING REMOVED DURING PRODUCT RETURN INVESTIGATION AS THE DEBRIS MAY HAVE DISLODGED FROM THE SENSOR PLUG OR SENSOR HOUSING AND LANDED IN THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) TRIANGLE INDICATING IT WAS NOT PRESENT PRIOR TO ITS REMOVAL. EXTENDED INVESTIGATION HAS BEEN INVESTIGATION. PQE (PRODUCT QUALITY ENGINEERING) PHYSICALLY INSPECTED THE RETURNED PUCK AND REVIEWED THE ATTACHMENT FROM THE PHASE 1 INVESTIGATION, AND OBSERVED DEBRIS(FIBER) IN THE PLUG TRIANGLE AREA. PQE DETERMINED THE DEBRIS(FIBER) OBSERVED ON THE PLUG TRIANGLE AREA IS NOT A CONTRIBUTING FACTOR TO THIS COMPLAINT. PQE DETERMINED THE DEBRIS AND SCRATCHES OBSERVED WERE NOT SEVERE ENOUGH TO HAVE ANY IMPACT ON THE SENSORS ACCURACY. THE RETURNED SENSOR WAS REPROGRAMMED FOR ACCURACY TESTING. THE CURRENT WAS APPLIED TO THE SENSOR TO PERFORM ACCURACY TESTING WHILE IN THE TEST FIXTURE. ALL RESULTS WERE WITHIN SPECIFICATION. POISE VOLTAGE AND SENSOR THERMISTOR TESTING WERE BOTH WITHIN SPECIFICATION, INDICATING THE SENSOR WAS PROVIDING ACCURATE GLUCOSE READINGS. NO ISSUES WERE FOUND DURING TESTING, THEREFORE, THIS ISSUE IS NOT CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO EITHER THE C, D, OR E ZONE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO EITHER THE C, D, OR E ZONE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941183 LIBRE 2 SENSOR FREESTYLE FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown