BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TROPONIN I ULTRA

    MDR report key: 5636788 · Received May 6, 2016

    Report

    Report Number
    3002769706-2016-00085
    Event Type
    Malfunction
    Date Received
    May 6, 2016
    Report Date
    April 20, 2016
    Manufacturer
    BIOMERIEUX SA
    Product Code
    MMI
    PMA / PMN Number
    K063243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT ASSOCIATED WITH VIDAS TROPONIN I ULTRA (TNIU) FOR CONTROL SAMPLE PROBIOQUAL (PBQ) 16MC02. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THREE PROBLEMS WERE IDENTIFIED ON THE PROBIOQUAL REPORT FOR 16MC02 SAMPLE WITH VIDAS TNIU AND VIDAS HSTNI. CODING ERROR BETWEEN TWO VIDAS TECHNIQUES. ANSWER- AS RECOMMENDED BY PROBIOQUAL, VIDAS USERS ARE REQUIRED TO USE THE SORTING CODE XX FOR VIDAS TNIU AND US FOR VIDAS HSTNI. UNIT ERROR. ANSWER- DESPITE THE PROBIOQUAL RECOMMENDATIONS, RESULTS ENTERED AS ¿G/L INSTEAD OF NG/L FOR VIDAS TNIU. FOR THE 16MC02 SAMPLE, RESULTS OBTAINED WITH VIDAS TNIU (< 0.01 ¿G/L OR 10 NG/L) ARE LOWER THAN RESULTS OBTAINED WITH OTHER TECHNIQUES INCLUDING VIDAS HSTNI. ANSWER- PROBIOQUAL IDENTIFIED THE SAMPLE AS BEING A HUMAN MATRIX LOADED WITH RECOMBINANT TROPONIN I AND THAT THERE ARE NO EXPECTED VALUES FOR THE BIOMÉRIEUX TECHNIQUE. THE LEVEL OF CONTROL IS NOT ADAPTED TO VIDAS TNIU BUT IS ADAPTED TO VIDAS HSTNI. ARTIFICIAL SAMPLES HAVE A DIFFERENT BEHAVIOR FROM NATURAL SAMPLES. MORE THAN A DIFFERENCE OF CORRELATION BETWEEN TECHNIQUES, ARTIFICIAL AND NATURAL SAMPLES ARE NOT ANALYZED IN THE SAME WAY. FROM JAN2015 TO 13MAY2016, THERE WERE NO SENSITIVITY ISSUE COMPLAINTS FOR VIDAS TNIU AND VIDAS HSTNI. VIDAS TNIU AND VIDAS HSTNI PERFORMED WITHIN EXPECTED SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF A FALSE NEGATIVE RESULT ASSOCIATED WITH VIDAS TROPONIN I ULTRA (TNIU) FOR CONTROL SAMPLE PROBIOQUAL (PBQ) 16MC02. THE DISCREPANT RESULT DID NOT RESULT IN NEGATIVE PATIENT IMPACT OR ADVERSE EVENT. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291786 VIDAS® TROPONIN I ULTRA VIDAS® TROPONIN I ULTRA MMI BIOMERIEUX SA 1004421900

    Patients

    Seq Age Sex Outcome Treatment
    1