BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT AUTO CLINICAL SAFETY LANCET - TENDER

    MDR report key: 5018704 · Received August 12, 2015

    Report

    Report Number
    1058955-2015-00010
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    December 6, 2010
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NURSES CLAIMED THEY NEEDED SEVERAL DEVICES TO GET A BLOOD SAMPLE. IT WAS THEIR IMPRESSION THERE WERE NO NEEDLES IN THE DEVICES. ACCORDING TO THE HEALTH SERVICE MANAGER THE ISSUE WAS WITH ONE SPECIFIC BOX OF DEVICES AND NOT SEVERAL BOXES FROM THE LOT THEY HAD. (THE ORIGINAL COMPLAINT, (B)(4), FOR THIS PRODUCT RETURN WAS CLOSED ON (B)(6) 2010. THIS NEW COMPLAINT (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

    IT TOOK SEVERAL DEVICES TO PRODUCE A BLOOD SAMPLE IN PATIENTS. CUSTOMER SUSPECTED THAT THE NEEDLES WERE MISSING FROM THE DEVICES THAT DID NOT PERFORM AS EXPECTED. NO DEVICES WERE KEPT. STAT MEDICAL DEVICES EVALUATED SAMPLES FROM THE SAME LOT OF DEVICES AND COULD NOT REPRODUCE THE FAILURE. BY VISUAL INSPECTION, IT WAS CONFIRMED THAT THE NEEDLES WERE PRESENT IN ALL DEVICES. ONE RANDOM BOX OF SAT PRODUCT OF THE SAME LOT (00147) OF PRODUCT IN INVENTORY WAS PULLED. PRIOR TO FIRING EACH DEVICE THEY WERE EXAMINED TO DETERMINE IF EACH DEVICE CONTAINED A NEEDLE. ALL DEVICES WERE FOUND TO CONTAIN NEEDLES. THE DEVICES WERE TESTED BY FIRING THE LANCETS INTO A STACK OF PAPER. THEN THE NUMBER OF PAPERS PENETRATED WERE COUNTED. ALL DEVICES PENETRATED THE NUMBER OF PAGES REQUIRED BY THE SPECIFICATION. THE FAILURE OF A SINGLE BOX OF PRODUCT OUT OF A LARGE LOT IS NOT LOGICALLY CONSISTENT WITH THE RANDOMNESS AND HIGH INCIDENCE OF HIGH-VOLUME FACTORY ERRORS. THIS IS MORE SUGGESTIVE OF A USER ERROR (DROPPED BOX, PRODUCT MISUSE OR REUSE). ALSO THE HIGH PERCENTAGE OF PENETRATION FAILURES INFERRED BY THESE TEST RESULTS IS NOT CONSISTENT WITH THE LOW INCIDENCE FROM FIVE YEARS OF COMPLAINT TRENDING (SEE BELOW). IMPROVEMENTS WERE MADE TO THE MANUFACTURING PROCESS IN 2010. CHANGE REQUEST (B)(4), RELEASED 02/24/2010, LISTS THE SEVERAL WORK INSTRUCTIONS THAT WERE REPLACED BY THE STAT AUTO CLINICAL SAFETY LANCET PRODUCTION WORK INSTRUCTION. THIS INSTRUCTION ADDED SPECIFIC REQUIREMENTS FOR PRODUCTION PENETRATION TESTS, INCLUDING THE DETAILED SPECIFICATION FOR THE PAPER TO BE USED, AND THE NUMBER OF SHEETS THAT THE NEEDLE IS REQUIRED TO PENETRATION FOR ACCEPTANCE. ALSO, STAT-LET AUTO LITE VALIDATION SUMMARY REPORT WAS RELEASED (2011-05-25) THAT DEMONSTRATES THIS MORE TIGHTLY CONTROLLED PROCESS. EIGHT ENGINEERING REPORTS IN 2014 ((B)(4)) DEMONSTRATE THAT THE SMD AUTO SAFETY LANCET PENETRATION PERFORMANCE MEETS ACCEPTANCE LIMITS. TREND ANALYSIS INDICATES THAT THE PENETRATION COMPLAINT COUNTS AND RATES (AS A PERCENTAGE OF SALES) DO NOT SHOW A TREND: 3 COMPLAINTS IN 2010 (0.005%), 0 IN 2011, 0 IN 2012, 1 IN 2013 (0.001%), AND 4 IN 2014 (0.05%). THE SMD AUTO SAFETY LANCET FMEA LIST NON-PENETRATION AS A RPN OF 3, WHICH IS A RELATIVELY LOW OVERALL RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531128 STAT AUTO CLINICAL SAFETY LANCET - TENDER AUTO- TENDER FMK STAT MEDICAL DEVICES, INC. SAT-100 00147

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other