BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX LANCET

    MDR report key: 1171430 · Received September 17, 2008

    Report

    Report Number
    1823260-2008-06928
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    CALLER STATES THE LANCET PROTRUDED BEYOND THE END CAP OF THE MULTICLIX DEVICE AFTER FIRING. NO ACCIDENTAL NEEDLESTICK REPORTED. NO ADVERSE EVENT REPORTED. REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK MULTICLIX LANCET LANCET- NA FMK ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK