BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1083625 · Received July 29, 2008

    Report

    Report Number
    1823260-2008-05834
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 250 MG/DL ON THE COMPACT PLUS SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 101 MG/DL ON THE DOCTOR'S SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NO ACTION OR TREATMENT RESULTED. REPORTER STATED THAT AT A DIFFERENT TIME ANOTHER COMPARATIVE TEST OF 309 MG/DL WAS PERFORMED BACK TO BACK WITH A RESULT OF 87 MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. REPORTER INDICATED THAT HE WAS EXPERIENCING SOME HYPOGLYCEMIC SYMPTOMS AND HE SELF-TREATED WITH FOOD. NO OTHER ACTIONS WERE REPORTEDLY 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 20678541

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR LANTUS - 2 YEARS - 70 UNITS AS NEEDED| METFORMIN - 3 YEARS - 500 MG TWICE DAILY