BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1170821 · Received September 15, 2008

    Report

    Report Number
    1823260-2008-06894
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF AROUND 500MG/DL AND AROUND 200-300MG/DL ON THE ACCU-CHEK COMPACT SYSTEM WITHIN A TEN MIN TIMEFRAME. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    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 20677141

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR MOBIC| FERROUS SULFATE| PRAVACHOL| ZANTAC| LASIX| COLACE| GLUCOTROL XL| NORVASC| AMLODIPINE