BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1061139 · Received June 13, 2008

    Report

    Report Number
    1823260-2008-04717
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE COMPACT PLUS SYSTEM WITH RESULTS OF 543 MG/DL AND 202 MG/DL. NO QUALITY CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT, AND A REPLACEMENT 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 CORP. 20678641

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR HUMALOG:: 75/25 32 UNITS PM| ETHAMBUTOL: 400MG/DAY| VITAMIN B6: 50MG/DAY| ISONIAZID: 300MG/DAY| RIFAMPIN: 600MG/DAY| PYRAZINAMIDE: 1500MG/DAY| CLONIDINE: 0.02 MG 2X/DAY| VITORIN: 10-20MG/DAY| RANITIDINE 150 MG/DAY| HUMALOG: 75/25 30 UNITS AM| TERAZOSIN: 5MG/DAY- 1 YEAR| GLYBURIDE: 10 MG 2X/DAY| FUROSEMIDE: 20MG/DAY -2 MTHS| CARTIA: 40MG/DAY-