BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1062356 · Received June 18, 2008

    Report

    Report Number
    1823260-2008-04801
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A DISCREPANT BLOOD GLUCOSE RESULT OF HI (GREATER THAN 600 MG/DL) BACK TO BACK WITH A RESULT IN THE 200-299 MG/DL RANGE ON THE COMPACT PLUS SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. NO 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 20675941

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR BUMETANIDE: 2MG ONCE DAILY| LANTUS: 10 UNITS ONCE DAILY - SINCE APRIL| POTASSIUM: 10MEQ TWICE DAILY| METOLAZONE: 2.5 MG ONCE DAILY| OXYGEN: CONTINUOUSLY| COUMADIN: 4 MG ONCE DAILY| PREDNISONE: 10 MG ONCE DAILY| POLY IRON: 150MG ONCE DAILY| CARVEDILOL: 3.125MG TWICE DAILY| ZEMPLAR: 1MCG ONCE DAILY| STOOL SOFTENER: 100 MG 2 TABS ONCE DAILY