BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1002109 · Received February 20, 2008

    Report

    Report Number
    1823260-2008-01730
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE REPORTER (PHARMACIST) STATES THAT THE LANCET PROTRUDES PAST THE CAP OF THE ACCU-CHEK MULTICLIX LANCET DEVICE. THE REPORTER (PHARMACIST) DID NOT CONFIRM THAT THE LANCET DEVICE PROTRUDED BEFORE OR AFTER FIRING. THE CUSTOMER LATER STATED THAT THE LANCET DID NOT PROTRUDE PAST THE CAP BEFORE TAKING IT TO THE PHARMACY. HOWEVER, THE CUSTOMER DID NOT CONFIRM THAT LANCET DID NOT PROTRUDE PAST CAP AT THE PHARMACY. NO REPORTED ACTIONS TAKEN. NO ACCIDENTAL STICK OR ADVERSE EVENT REPORTED. NEW LANCET DEVICE WITH LANCETS SENT AND RETURN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR NO MEDICATIONS