BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TROPONIN I ULTRA

    MDR report key: 5574394 · Received April 13, 2016

    Report

    Report Number
    3002769706-2016-00066
    Event Type
    Malfunction
    Date Received
    April 13, 2016
    Report Date
    June 14, 2017
    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 REPORTED A DISCREPANT RESULT WHEN USING THE VIDAS® TROPONIN TEST KIT (REF 30448). THE CUSTOMER OBTAINED A NEGATIVE RESULT ON THE VIDAS® INSTRUMENT WITH THE TROPONIN KIT WHICH LED TO THE DISCREPANT RESULT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THREE (3) PROBLEMS WERE CONFIRMED DURING THE COMPLAINT INVESTIGATION. A CODING ERROR BETWEEN TWO VIDAS® TECHNIQUES, UNIT ERROR; RESULTS OBTAINED WITH VIDAS TROPONIN I (LESS THAN 0.01 UG/L OR 10 NG/L) ARE LOWER THAN RESULTS OBTAINED WITH OTHER TECHNIQUES INCLUDING VIDAS HSTNI (REF 415386). THE SOLUTIONS TO THESE PROBLEMS ARE AS FOLLOWS: CODING ERROR; AS RECOMMENDED BY PROBIOQUAL THROUGH MAILING AND REPORTS, THE VIDAS USERS HAVE TO USE THE SORTING CODE XX FOR VIDAS TNIU (REF 30448) AND US FOR VIDAS HSTNI (REF 415386). UNIT ERROR; REMINDER INDICATED IN PROBIOQUAL REPORT : AS HIGH SENSITIVE TECHNIQUES ARE MORE AND MORE REPRESENTED, WE NOW USE NG/L AS UNIT. NG/L IS THE UNIT RECOMMENDED BY SCIENTISTS SOCIETIES OF CARDIOLOGY. DESPITE THE PROBIOQUAL RECOMMENDATIONS, SOME VIDAS USERS ENTERED THEIR RESULTS IN UG/L INSTEAD OF NG/L FOR VIDAS TNIU (REF 30448). QP LABORATORY ANTICIPATED THIS POTENTIAL PROBLEMS OF UNITS AND ASKED PBQ TO ADD A SCROLLING MENU TO CHOOSE UNIT WHEN ENTERING RESULTS AT THE BEGINNING OF 2016 (APPENDIX 3) RESULTS OBTAINED WITH VIDAS TROPONIN I; QP ASKED PROBIOQUAL FOR PRECISIONS ABOUT SAMPLE COMPOSITION AND EXPECTED VALUES (APPENDIX 1) : ANSWER FROM PROBIOQUAL: THE SAMPLE IS A HUMAN MATRIX LOADED WITH RECOMBINANT TROPONIN I. THERE ARE NO EXPECTED VALUES FOR BIOMÉRIEUX TECHNIQUE. THIS LEVEL OF CONTROL IS NOT ADAPTED TO VIDAS TNIU (REF 30448) BUT IS ADAPTED TO VIDAS HSTNI (REF 415386). WE KNOW THAT 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. VIDAS TNIU (REF 30448) AND VIDAS HSTNI (REF 415386) ARE WITHIN EXPECTED SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A DISCREPANT RESULT WHEN USING THE VIDAS TROPONIN TEST KIT (REF 30448). THE CUSTOMER OBTAINED A NEGATIVE RESULT ON THE VIDAS INSTRUMENT WITH THE TROPONIN KIT WHICH LED TO THE DISCREPANT RESULT. TESTING THROUGH OTHER METHODS OBTAINED A POSITIVE RESULT. AN INVESTIGATION INTO THIS EVENT HAS BEEN INITIATED BY BIOMERIEUX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229781 VIDAS® TROPONIN I ULTRA VIDAS® TROPONIN I ULTRA MMI BIOMERIEUX SA 1004025610

    Patients

    Seq Age Sex Outcome Treatment
    1