BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX LANCETS

    MDR report key: 2014255 · Received March 10, 2011

    Report

    Report Number
    1823260-2011-01334
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 2, 2011
    Report Date
    April 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    REPORTER ALLEGED THE NEEDLE FROM THE NEW MULTICLIX LANCET DRUM PROTRUDES OUTSIDE OF IT WHEN IT WAS JUST TAKEN OUT OF THE BOX. NO ACTIONS OR TREATMENTS WERE REPORTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MULTICLIX LANCETS LANCET FMK ROCHE DIAGNOSTICS NA WP100061

    Patients

    Seq Age Sex Outcome Treatment
    1