BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® LANCETS

    MDR report key: 2083439 · Received May 10, 2011

    Report

    Report Number
    1823260-2011-02497
    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
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 SOFTCLIX NEEDLE WAS EXPOSED 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 SOFTCLIX ® LANCETS LANCET FMK ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1