BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 971991 · Received December 28, 2007

    Report

    Report Number
    1823260-2007-11211
    Event Type
    Malfunction
    Date Received
    December 28, 2007
    Date of Event
    December 5, 2007
    Report Date
    December 28, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE LANCET PROTRUDES PAST THE END OF THE CAP OF THE ACCU-CHEK MULTICLIX LANCET DEVICE BEFORE IT IS FIRED. THE REPORTER ALSO STATES THAT HE WAS ACCIDENTALLY STUCK, BUT DID NOT REQUIRE MEDICAL ATTENTION. NO ACTIONS/INACTIONS REPORTED. BASED ON PRODUCT INVESTIGATION IT WAS DISCOVERED THAT THE LANCET DOES NOT RETRACT UPON FIRING THE ACCU-CHEK MULTICLIX LANCET DEVICE. NO ADVERSE EVENT REPORTED. THE ACCU-CHEK CUSTOMER CARE SERVICE CENTER SENT NEW DEVICE. CUSTOMER ADVISED TO RETURN SUSPECT DEVICE.

    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 55 YR