BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1110383 · Received August 14, 2008

    Report

    Report Number
    1823260-2007-05264
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    May 23, 2007
    Report Date
    June 15, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED DISCREPANT BACK-TO-BACK BLOOD GLUCOSE RESULTS OF HI (>600MG/DL) ON THE COMPACT SYSTEM COMPARED TO 105 MG/DL ON A PROFESSIONAL METER WHEN TESTS WERE PERFORMED WITHIN 10 MINUTES. IT WAS REPORTED THAT THE CUSTOMER HAD NO SYMPTOMS AND DID NOT TREAT/ACT ON THE RESULT. 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 20659241

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR VITAMIN| NEXIUM| VYTORIN| MEFTORMIN - 4 MONTHS 850 MG DAILY