BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIDAS® HS TROPONIN I

    MDR report key: 6930949 · Received October 9, 2017

    Report

    Report Number
    3002769706-2017-00293
    Event Type
    Injury
    Date Received
    October 9, 2017
    Date of Event
    May 24, 2017
    Report Date
    October 9, 2017
    Manufacturer
    BIOMERIEUX SA
    Product Code
    MMI
    PMA / PMN Number
    K063243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: NO CAPA NOR NON-CONFORMITY LINKED TO THE CUSTOMER'S COMPLAINT WERE RECORDED ON VIDAS TNHS PARAMETER "REF 415386". THE ANALYSIS OF THE BATCH HISTORY RECORDS SHOWED NO ANOMALY. THE QUALITY PRODUCT LABORATORY HAS TESTED 5 INTERNAL SAMPLES : ALL THE RESULTS WERE WITHIN THEIR SPECIFICATION. SO THE VIDAS® TNHS LOT 1005467700 / 180416-0 IS WITHIN ITS ACCEPTANCE CRITERIA. THE CUSTOMER'S SAMPLE WAS FORWARDED TO THE R&D DEPARTMENT FOR FURTHER INVESTIGATION. THE SAMPLE WAS TESTED ON : VIDAS® HS TNI REF.30448 AND VIDAS® HS TNI REF.415386 BATCH 180602-0 (THE BATCH NUMBER IS DIFFERENT FROM THE ONE MENTIONED BY THE CUSTOMER). THE RESULT WAS NEGATIVE WITH VIDAS® HS TNI REF.30448, AND THE RESULT WAS 169.9 NG/L WITH VIDAS® HSTNI REF.415386. A DILUTION TEST WAS PERFORMED IN ORDER TO CHECK IF THE POTENTIAL INTERFERENCE COULD BE ELIMINATED, THE RESULTS OBTAINED AFTER DILUTION INCREASED COMPARED TO THE RESULT OBTAINED ON THE UNDILUTED SERUM. THIS IS IN FAVOR OF AN INTERFERENCE BUT THIS BEHAVIOR WAS DIFFERENT FROM THAT USUALLY ENCOUNTERED (HETEROPHILIC ANTIBODIES, RHEUMATOID FACTORS, ANTI-TROPONIN AUTOANTIBODIES). UNFORTUNATELY, THE LACK OF VOLUME DID NOT ALLOW US TO IDENTIFY THE NATURE OF THIS INTERFERENCE. HOWEVER AS THE VIDAS® HSTNI BATCH NUMBER USED BY QUALITY PRODUCT LAB IS DIFFERENT THAN THE CUSTOMER'S BATCH , WE CAN EXCLUDE AN INTERFERENCE LINKED TO THE BATCH. THE INSTRUCTIONS FOR USE - LIMITATIONS OF THE METHOD SECTION, IT'S WRITTEN THAT "INTERFERENCE MAY BE ENCOUNTERED WITH CERTAIN SAMPLES CONTAINING ANTIBODIES DIRECTED AGAINST REAGENT COMPONENTS. FOR THIS REASON, ASSAY RESULTS SHOULD BE INTERPRETED TAKING INTO CONSIDERATION THE PATIENT'S CLINICAL HISTORY, AND THE RESULTS OF ANY OTHER TESTS PERFORMED."

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VIDAS® HS TROPONIN I (REFERENCE 415386). ON (B)(6) 2017, A (B)(6) FEMALE PATIENT HAD A SAMPLE TESTED WITH HS TROPONIN I AND THE RESULT WAS 108 NG/L. THE PATIENT WAS TRANSFERRED TO A HOSPITAL AND A SAMPLE WAS TESTED AGAIN. THE SECOND TEST RESULT WAS 3 NG/L. ON (B)(6) 2017 THE PATIENT SAMPLE WAS TESTED AGAIN WITH VIDAS® AND THE RESULT WAS 120 NG/L. THE SAME SAMPLE WAS REPEATED ON VIDAS® AND THE SAMPLE RESULT WAS 130 NG/L. THE SAMPLE WAS SENT TO TWO (2) DIFFERENT LABORATORY CHAINS WHERE BOTH USE ROCHE AND THE RESULTS WERE 3 NG/L. THE PATIENT IS TAKING LAPRAZOL MEDICATION FOR ESOPHAGITIS AND VITAMIN D AND C TABLETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710060 VIDAS® HS TROPONIN I VIDAS® HS TROPONIN I MMI BIOMERIEUX SA 415386 1005467700

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization