BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FS OPT B-KET-NO CODING

    MDR report key: 17343390 · Received July 18, 2023

    Report

    Report Number
    2954323-2023-31025
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 23, 2023
    Report Date
    July 18, 2023
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    PMA / PMN Number
    K193371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED FOR THE LIBRE READER. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. A TRIPPED TREND REVIEW WAS CONDUCTED FOR THE REPORTED COMPLAINT AND LIBRE READER, NO TRENDS WERE IDENTIFIED THAT WOULD INDICATE ANY PRODUCT RELATED ISSUES. THE DHRS (DEVICE HISTORY REVIEW) FOR THE PRECISION STRIPS WAS REVIEWED AND THE DHRS SHOWED THE PRECISION STRIPS PASSED ALL TESTS PRIOR TO RELEASE. RETAIN TESTING WAS PERFORMED FOR PRECISION STRIPS, AND ALL UNITS PERFORMED IN SPECIFICATION AND PASSED. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED, AND A FOLLOW-UP REPORT SUBMITTED. UPON EXTENDED INVESTIGATION, IT WAS DETERMINED THAT THE SERIAL NUMBER PROVIDED BY THE CUSTOMER (B)(6) WAS NOT A VALID SERIAL NUMBER. THEREFORE, SECTION D4 WAS UPDATED TO UNK. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766499 FS OPT B-KET-NO CODING FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71953-01 4500186864

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown