BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1220065 · Received October 31, 2008

    Report

    Report Number
    1823260-2008-08071
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET DID NOT RETRACT INTO MULTICLIX DEVICE AFTER FIRING, LANCET IS PROTRUDING FROM DEVICE CAP. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE 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 35 YR NEXIUM| "KLOR-CON M20"| MULTIVITAMIN| TYLENOL| LITHIUM| "HELDAPROL"| LASIX| "COLONATEN"| ZANTAC| MECLIZINE| "CYPROFLAXZSEE"| VOLTAREN GEL| PROMETHAZINE