BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 1951044 · Received January 6, 2011

    Report

    Report Number
    1823260-2011-00076
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    MANUFACTURER'S FIRST LEVEL INVESTIGATIONAL UNIT CONFIRMED THE LANCET PROTRUDES BEYOND THE END CAP OF THE MULTICLIX DEVICE. NO ADVERSE EVENT REPORTED. SUSPECT DEVICE HAS BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA GWX046

    Patients

    Seq Age Sex Outcome Treatment
    1