BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1181691 · Received September 30, 2008

    Report

    Report Number
    1823260-2008-07258
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 30, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE LANCET DOES NOT RETRACT BACK INTO THE CAP OF THE ACCU-CHEK MULTICLIX LANCET DEVICE AFTER FIRING. NO ACTION TAKEN OR TREATMENT GIVEN BASED ON THE LANCET DEVICE ISSUE. NO ACCIDENTAL STICK OR ADVERSE EVENT REPORTED. THE CUSTOMER DOES NOT HAVE THE LANCET DEVICE OR LANCETS WITH HER AT THE TIME OF THE CALL TO OBTAIN PRODUCT INFORMATION. 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 MULTICLIX LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR METFORMIN - 2 MONTHS