BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® PLUS GT LANCET DEVICE

    MDR report key: 3230069 · Received July 16, 2013

    Report

    Report Number
    1823260-2013-04276
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 18, 2013
    Report Date
    September 18, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE SOFTCLIX PLUS DEVICE. CALLER DROPPED THE LANCET DEVICE TODAY, AND THE TOP CAP AND LANCET CARRIER BROKE OFF. SHE ALSO NOTICED THE LANCET WAS PROTRUDING PAST THE CAP. NO ACCIDENTAL STICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329710 SOFTCLIX ® PLUS GT LANCET DEVICE LANCET DEVICE FMK ROCHE DIAGNOSTICS NA BAU073

    Patients

    Seq Age Sex Outcome Treatment
    1