BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® PLUS GT LANCET DEVICE

    MDR report key: 3981563 · Received August 5, 2014

    Report

    Report Number
    1823260-2014-05897
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 9, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER IS UNKNOWN. IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE SOFTCLIX PLUS DEVICE. NO ACCIDENTAL NEEDLE STICK REPORTED. NO DEATH OR SERIOUS INJURY REPORTED. ATTEMPTS TO FOLLOW UP WITH CUSTOMER HAVE BEEN UNSUCCESSFUL; AWAITING CUSTOMER REPLY BEFORE SENDING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456629 SOFTCLIX ® PLUS GT LANCET DEVICE LANCET DEVICE FMK ROCHE DIAGNOSTICS NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1