BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 2083550 · Received May 10, 2011

    Report

    Report Number
    1823260-2011-02505
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    PHARMACIST CALLED FOR CUSTOMER, REPORTED LANCET PROTRUDING FROM MULTICLIX DEVICE CAP. NO ADVERSE EVENT REPORTED. CUSTOMER INFORMATION WAS NOT AVAILABLE TO REQUEST RETURN, SEND REPLACEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1