BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1220085 · Received October 31, 2008

    Report

    Report Number
    1823260-2008-08095
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 26, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 54 MG/DL, 138 MG/DL, 82 MG/DL AND 62 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINS ON THE COMPACT PLUS SYSTEM. RPTR INDICATED THAT SHE WAS EXPERIENCING SOME HYPOGLYCEMIC SYMPTOMS AND SHE SELF-TREATED WITH ORANGE JUICE, CRACKERS, CHEESE, AND A GLUCOSE TAB. RPTR ALLEGED THAT SHE OBTAINED BACK TO BACK RESULTS AGAIN SIMILAR TO THOSE ABOVE ON ANOTHER NIGHT, BUT SHE WOULD NOT CLARIFY EXACTLY WHAT THOSE RESULTS WERE. 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