BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT QWIK-LET LANCING DEVICE

    MDR report key: 5021527 · Received August 13, 2015

    Report

    Report Number
    1058955-2015-00021
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    January 23, 2012
    Report Date
    August 10, 2015
    Manufacturer
    STAT MEDICAL DEVICES, INC.
    Product Code
    FMK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL (B)(4), FOR THIS PRODUCT RETURN WAS CLOSED ON 01/26/2012. THIS NEW (B)(4) WAS OPENED AFTER CONSULTATION WITH THE EMERGO GROUP ON THE RE-ASSESSMENT OF THE MDR SUBMISSION FOR THIS RETURNED PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER INDICATES A "NOVA CUSTOMER REPRESENTATIVE HAD TO REPLACE 8 SUREFLES LANCING DEVICES THAT WERE NOT WORKING (NEW OUT OF THE BOX). ALL LANCING DEVICES WERE FROM DEVICE LOT TINB0511-1. A COMPLAINT WAS LOGGED AT NOVA BIOMEDICAL ON (B)(6) 2011 AND WAS GIVEN A (B)(4). SIX LANCING DEVICES WERE RETURNED TO NOVA BIOMEDICAL'S COMPLAINT LAB AND WERE CONFIRMED TO BE DEFECTIVE (NOT WORKING). FIVE OF THE LANCERS APPEARED TO BE MISSING THE BOTTOM SPRING. ALL 6 LANCETS WERE SHIPPED TO STAT MEDICAL DEVICES FOR INVESTIGATION OF ROOT CAUSE AND CORRECTIVE ACTIONS". THE RETURNED SAMPLES WERE ANALYZED. THE TAB ON THE ENGINE WAS FORCED BEYOND THE TAB ON THE BUTTON. THE RESULT WAS THAT THE BUTTON COULD NOT RELEASE THE ENGINE, THUS LOCKING THE DEVICE. THIS MOST LIKELY HAPPENED ON LANCET INSERTION. IF EXCESSIVE FORCE IS USED, THE DEVICE CAN BE LOCKED INT HIS MANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533089 STAT QWIK-LET LANCING DEVICE LANCING DEVICE FMK STAT MEDICAL DEVICES, INC. NOVA SUREFLEX TINB0511-1

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other