BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT PLUS

    MDR report key: 1780360 · Received September 14, 2007

    Report

    Report Number
    1823260-2007-08094
    Event Type
    Malfunction
    Date Received
    September 14, 2007
    Date of Event
    August 22, 2007
    Report Date
    September 14, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED BLOOD GLUCOSE RESULTS FROM COMPACT PLUS SYSTEM AS RECORDED IN HER DIARY FOR A 2-DAY PERIOD ARE: 252 MG/DL, 141 MG/DL, 103 MG/DL, 66 MG/DL, 47 MG/DL, 107 MG/DL, 116 MG/DL, AND 210 MG/DL. CUSTOMER ALLEGED RESULTS FROM THE SAME PERIOD FROM THE METER'S MEMORY: 116 MG/DL, 66 MG/DL, 210 MG/DL, 174 MG/DL, 189 MG/DL, AND 93 MG/DL. NO SERIOUS ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THE MEMORY DISCREPANCY. 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 PLUS BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR NORVASC - YEARS - 5MG DAILY| LIPITOR - YEARS - 10MG DAILY| GLYBURIDE - 5MG TWICE DAILY| ASPIRIN - YEARS - 81MG DAILY| LANTUS - 8UNITS DAILY| DISOPYRAMIDE - YEARS - 150MG TWICE DAILY| AVAPRO - YEARS - 75MG DAILY| DIGOXIN - YEARS - 125MCG DAILY