BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QWIKLET ULTIMATE LANCING DEVICE

    MDR report key: 5018701 · Received August 12, 2015

    Report

    Report Number
    1058955-2015-00011
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    June 16, 2011
    Report Date
    August 5, 2015
    Manufacturer
    STAT MEDICAL DEVICES, INC.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL (B)(4), FOR THIS PRODUCT RETURN WAS CLOSED ON 08/24/2011. THE CUSTOMER THEN RETURNED 12 DEVICES CLAIMING THEY WERE THE ACTUAL FAILURES. THE COMPLAINT WAS REOPENED AND CLOSED AGAIN 09/14/2011. THIS NEW (B)(4) WAS OPENED AFTER CONSULTATION WITH THE (B)(4) ON THE RE-ASSESSMENT OF THE MDR SUBMISSION FOR THIS RETURNED PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER HAS INDICATED THEY HAVE RECEIVED A DOZEN COMPLAINTS FROM THEIR CUSTOMERS THAT THE DEVICES ARE BREAKING AND DO NOT PENETRATE THE SKIN. THE CUSTOMER INDICATED THE SAMPLES COULD NOT BE RETURNED. TWENTY ULTIMATE LANCING DEVICE SAMPLES FROM VARIOUS LOTS WERE TAKEN FROM STAT INVENTORY AND TESTED BY COCKING AND FIRING THE DEVICE AT EACH OF THE EIGHT (8) DEPTH SETTINGS INTO 0.09 INCH THICK STACKS OF PAPER. THE NUMBER OF PENETRATED PAGES WAS COUNTED; ALL 20 SAMPLES COCKED SUCCESSFULLY 100% OF THE TRIALS AND MET THE PRODUCTION SPECIFICATION FOR PAPER PENETRATION. ON 09/14/2011, THE CUSTOMER RETURNED TWELVE (12) ULTIMATE LANCING DEVICES WITH NO OTHER INFORMATION. EACH DEVICE WAS JAMMED STUCK IN THE COCKED POSITION. AFTER MANUALLY UNJAMMING THE COCKING MECHANISMS, ALL RETURNED SAMPLES PASSED THE COCKING PENETRATION TESTS DESCRIBED EARLIER. THE JAMMED CONDITION COULD NOT BE REPRODUCED, EVEN WITH MISUSE MANIPULATION BY INSERTING THE LANCET WITH EXTREME FORCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531119 QWIKLET ULTIMATE LANCING DEVICE LANCING DEVICE FMK STAT MEDICAL DEVICES, INC. QLU-L02 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other