BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® PLUS GT LANCET DEVICE

    MDR report key: 2870338 · Received December 12, 2012

    Report

    Report Number
    1823260-2012-06297
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    October 18, 2012
    Report Date
    January 30, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    UPON REVIEW BY THE MANUFACTURER'S INVESTIGATION UNIT, THE LANCET WAS FOUND TO PROTRUDE PAST THE END CAP OF THE SOFTCLIX PLUS DEVICE. NO ACCIDENTAL STICK OCCURRED. NO ADVERSE EVENT REPORTED. DEVICE WAS RETURNED AND REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX ® PLUS GT LANCET DEVICE LANCET DEVICE FMK ROCHE DIAGNOSTICS NA BAV037

    Patients

    Seq Age Sex Outcome Treatment
    1