BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 864130 · Received April 5, 2007

    Report

    Report Number
    1823260-2007-02803
    Event Type
    Malfunction
    Date Received
    April 5, 2007
    Date of Event
    February 19, 2007
    Report Date
    April 5, 2007
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 250 MG/DL AND 50 MG/DL ON THE COMPACT SYSTEM WITHIN 10 MINUTES. CUSTOMER REPORTS LOW BLOOD SYMPTOMS WITH THESE RESULTS; SELF TREATED WITH OJ. THE CUSTOMER DID NOT PROVIDE THE LOCATION WHERE THE DISCREPANT RESULTS WERE OBTAINED. NO ADVERSE EVENT REPORTED. NO QUALITY CONTROLS WERE USED. REQUESTED RETURN OF SUSPECT DEVICE AND 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. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR HUMALOG AM AND DINNER| HUMULIN AM PM