BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1832206 · Received September 13, 2010

    Report

    Report Number
    1823260-2010-05384
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    MANUFACTURER'S FIRST LEVEL INVESTIGATIONAL UNIT OBSERVED 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 GWW021

    Patients

    Seq Age Sex Outcome Treatment
    1