BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAZZ CVS BGMS

    MDR report key: 7378291 · Received March 28, 2018

    Report

    Report Number
    3004637226-2018-00003
    Event Type
    Injury
    Date Received
    March 28, 2018
    Report Date
    March 26, 2018
    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. NEITHER THE METER SERIAL NUMBER NOR THE TEST STRIP LOT NUMBER WAS PROVIDED. THE OWNER'S GUIDE AND PREVIOUS FIELD RETURNS HAVE BEEN REVIEWED. THERE WAS NO INFORMATION ON THE MEDICATION THE USER IS TAKING. THIS SYSTEM WAS PREVIOUSLY TESTED AGAINST COMMON INTERFERENTS IN THE BLOOD AND FOUND ASCORBIC ACID (>2 MG/DL) CAN INTERFERE WITH A BLOOD-GLUCOSE CONCENTRATION CALCULATION. THIS IS PRINTED IN THE TEST STRIP INSERT. ERRORS 3, 4, AND 6 ARE DESCRIBED IN THE OWNER'S GUIDE AS: ERROR 3: THE METER HAS DETECTED THAT THE TEST STRIP IS IN POOR CONDITION OR TEST STRIP CONNECTOR MAY BE DIRTY. ERROR 4: THE METER WAS UNABLE TO PRODUCE A RESULT OR UNUSUAL PROBLEMS HAVE OCCURRED THAT MAY BE RELATED TO EXTREME CONDITIONS. ERROR 6: THE TEST STRIP HAS TAKEN TOO LONG TO GENERATE A SIGNAL (POSSIBLE CAUSE: COMBINATION OF COLD OPERATING TEMPERATURE AND HIGH HEMATOCRIT). 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 ERRORS 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'S SON IS THE USER ((B)(6)), COMING OUT OF THE HOSPITAL TODAY (DIALYSIS, KIDNEY ISSUES), HIS BLOOD-GLUCOSE WAS REPORTED TO BE ALL OVER THE PLACE. THE CALLER HAD TO BRING HIS SON TO THE HOSPITAL LAST WEEK BECAUSE HE WAS NOT FEELING WELL. HE ATTEMPTED TO TAKE A BLOOD-GLUCOSE READING WITH THE CVS HEALTH ADVANCED, BUT WAS UNABLE TO DO SO. THE CVS METER DISPLAYED ERRORS 3, 4, AND 6 INSTEAD OF A RESULT. THERE IS NO INDICATION ON WHETHER ANY DECISIONS WERE MADE IN RESPONSE TO THE METER'S DISPLAY. NO OTHER INFORMATION, INCLUDING METER SERIAL NUMBER, TEST STRIP LOT INFORMATION, NOR MEDICAL TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221188 JAZZ CVS BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-10291

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| O