BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1181533 · Received September 25, 2008

    Report

    Report Number
    1823260-2008-07147
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE LANCET DID NOT RETRACT BACK INTO THE CAP OF THE ACCU-CHEK MULTICLIX LANCET DEVICE. SHE INITIALLY STATED THAT SHE IS NOT SURE IF THIS OCCURRED BEFORE OR AFTER FIRING. THE REPORTER ALSO STATED THAT SHE FOUND THE LANCET PROTRUDING PAST THE CAP OF THE LANCET DEVICE AFTER SHE RAN A TEST. NO ACTION TAKEN OR TREATMENT GIVEN BASED ON THE LANCET DEVICE ISSUE. 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 67 YR