BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH ADVANCED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 11754099 · Received April 30, 2021

    Report

    Report Number
    3004637226-2021-00001
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    April 11, 2021
    Report Date
    April 30, 2021
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K072413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED BUT HAS NOT BEEN RETURNED TO THE MANUFACTURER. TESTING CONDITIONS UNKNOWN THOUGH ALCOHOL WAS USED TO CLEAN THE SITE. THE OWNER'S GUIDE AND PREVIOUS FIELD RETURNS HAVE BEEN REVIEWED. IT IS NOT CLEAR AS TO HOW LONG AFTER THE INITIAL MEASUREMENT THE COMPARISON MEASUREMENT WAS MADE. THERE IS NO EVIDENCE FROM PREVIOUS FIELD RETURNS THE EVENT WAS CAUSED BY A METER MALFUNCTION. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED HIGH MEASUREMENT CANNOT BE DETERMINED. ENVIRONMENTAL FACTORS, MEDICAL CONDITIONS, AND TESTING PRACTICES COULD HAVE CONTRIBUTED. NO CORRECTIVE ACTION WILL BE PERFORMED AS SYSTEM FAILURE COULD NOT BE CONFIRMED. THIS COMPLAINT WILL CONTINUE TO BE TRENDED.

    Description of Event or Problem · 1

    THE CALLER REPORTED MEASURING HIS MOTHER'S BLOOD GLUCOSE, AFTER CLEANING THE SITE WITH ALCOHOL, AND THE CVS ADVANCED BLOOD GLUCOSE MONITOR DISPLAYED 584 MG/DL. THE PARAMEDICS WERE CALLED AND THEIR MEASUREMENT (DEVICE UNKNOWN) DISPLAYED 96 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651716 CVS HEALTH ADVANCED BLOOD GLUCOSE MONITORING SYSTEM BLOOD GLUCOSE MONITOR NBW AGAMATRIX, INC. 8000-10291

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other