BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1060104 · Received June 10, 2008

    Report

    Report Number
    1823260-2008-04598
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 10, 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

    CUSTOMER REPORTEDLY REC'D RESULTS OF 90 MG/DL AND 157 MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. CUSTOMER REPORTED NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUESTED WAS MADE FOR THE RETURN OF THE SYSTEM, 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 20678343

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK