BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT QWIK-LET LITE LANCING DEVICE

    MDR report key: 5021525 · Received August 13, 2015

    Report

    Report Number
    1058955-2015-00017
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    August 1, 2012
    Report Date
    August 10, 2015
    Manufacturer
    STAT MEDICAL DEVICES, INC.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL COMPLAINT, (B)(4), FOR THIS PRODUCT RETURN WAS CLOSED ON 08/29/2012. THIS NEW COMPLAINT (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 CALLED TO SAY THAT HE JUST RECEIVED ONE OF OUR LANCING DEVICES FROM THEIR MAIL ORDER GROUP (B)(4) AND THE DEVICE DOES NOT FIRE WHEN PULLING THE ARMING MECHANISM OUT. WORKED WITH CUSTOMER OVER THE PHONE TO ATTEMPT TO GET DEVICE ARMED AND FIRED, BUT COULD NOT. CUSTOMER COULD HOWEVER PUSH A LANCET INTO THE "ENGINE" AND FORCE THE MECHANISM BACK, WHICH THEN ALLOWED THE DEVICE TO BE FIRED WITH THE TRIGGER BUTTON. STAT MEDICAL RECEIVED AND ANALYZED THE QLL DEVICE. IT WAS DETERMINED THAT THE ACTUATOR BOTTOM WAS GLUED TO THE BOTTOM HOUSING. THE DEVICE WAS EITHER NOT TEST FIRED, OR SUCH AN EXTENSIVE AMOUNT OF GLUE WAS USED THAT THE GLUE WAS USED THAT THE GLUE WAS STILL WET WHEN IT WAS FIRED, THUS ALLOWING THE DEVICE TO OPERATE AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533157 STAT QWIK-LET LITE LANCING DEVICE FMK STAT MEDICAL DEVICES, INC. QLL-L02 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other