BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1133550 · Received August 22, 2008

    Report

    Report Number
    1823260-2008-06376
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 60 MG/DL BACK TO BACK WITH A RESULT OF 100 MG/DL ON THE COMPACT PLUS SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER INDICATED THAT SHE WAS EXPERIENCING SOME HYPOGLYCEMIC SYMPTOMS AFTER THE FIRST RESULT WAS OBTAINED AND SHE SELF-TREATED WITH ORANGE JUICE. REPORTER STATED SHE ALSO WENT TO THE HOSPITAL ABOUT 2.5 HOURS LATER AND THEY GAVE HER A SHOT FOR HER NERVOUS STOMACH. REPORTER STATED THAT HOURS AFTER THAT, A RESULT OF 80 MG/DL WAS OBTAINED ON THEIR SYSTEM, THEN SHE WAS GIVEN AN IV OF WHAT BELIEVES WAS INSULIN, ORAL MEDICATION, AND FOOD. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLAVIX| NORVASC