BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1761322 · Received July 20, 2007

    Report

    Report Number
    1823260-2007-06374
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    July 9, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED 2 SETS OF DISCREPANT BLOOD GLUCOSE VALUES ON THE COMPACT SYSTEM: 342 MG/DL & 119 MG/DL WITHIN 3 MINUTES, 324 MG/DL & 148 MG/DL WITHIN 3 MINUTES. THE CUSTOMER REPORTED NO SYMPTOMS WITH THE RESULTS. CUSTOMER DID NOT TREAT/ACT ON RESULTS. NO ADVERSE EVENTS RELATED TO THE ALLEGED MALFUNCTIONS WERE 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 20659801

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR ESTROPIPATE - 5MG DAILY| LANTUS - 5+ YEARS - 16 UNITS DAILY PM| ACTOS - 1 MONTH - DAILY| PRAVACHOL - 80MG DAILY| ASPIRIN - 1 MONTH - DAILY| DIOVAN HCT - 5+ YEARS - DAILY| METFORMIN - 5+ YEARS - TWICE DAILY| CLONIDINE - 5+ YEARS - 0.1MG DAILY| NORVASC - 5+ YEARS - 10MG DAILY