BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TEST DRUM

    MDR report key: 1191527 · Received September 26, 2008

    Report

    Report Number
    1823260-2008-07206
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 26, 2008
    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 FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY OBTAINED A 110MG/DL AND 300MG/DL ON THE ACCU-CHEK COMPACT PLUS SYSTEM WITHIN A TEN MINUTE TIMEFRAME. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. NO ADVERSE EVENT REPORTED. THE CALLER DID NOT PROVIDE STRIP INFO. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECTED PRODUCT, REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INSULIN(UNKNOWN TYPE)