BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FS OPT H KET-CODING

    MDR report key: 15786754 · Received November 14, 2022

    Report

    Report Number
    2954323-2022-41569
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    October 24, 2022
    Report Date
    November 23, 2022
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    PMA / PMN Number
    K040814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    REPEATED ATTEMPTS BY ADC TO RETRIEVE THE PRODUCT WERE UNSUCCESSFUL AND/OR THE CUSTOMER DISCARDED THE PRODUCT. NO PRODUCT HAS BEEN RETURNED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DHRS FOR THE XCEED OPTIUM METER WAS REVIEWED AND THE DHRS SHOWED THE XCEED OPTIUM METER PASSED ALL TESTS PRIOR TO RELEASE. DHRS 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. 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
    353148 FS OPT H KET-CODING BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC 98814-65 4500185979

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown