BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIDAS® HS TROPONIN I

    MDR report key: 6556388 · Received May 10, 2017

    Report

    Report Number
    3002769706-2017-00118
    Event Type
    Injury
    Date Received
    May 10, 2017
    Date of Event
    April 5, 2017
    Report Date
    June 20, 2017
    Manufacturer
    BIOMERIEUX SA
    Product Code
    MMI
    PMA / PMN Number
    K063243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION: THE ANALYSIS OF THE BATCH HISTORY RECORDS SHOWED NO ANOMALY DURING THE CONTROL FOR THESE THREE (3) BATCHES. NO CAPA NOR NON-CONFORMITY IS LINKED TO THE CUSTOMER COMPLAINTS REGARDING VIDAS® HSTNI PARAMETER (REF (B)(4)). THE SAMPLES RETURNED WERE FURTHER EVALUATED BY THE R&D DEPARTMENT. DURING THIS INVESTIGATION, AN INTERFERENCE WAS HIGHLIGHTED ON THE SAMPLES RETURNED BY THE CUSTOMER. THE NATURE OF THIS INTERFERENCE HAS NOT BEEN IDENTIFIED AND WOULD BE DIFFERENT FROM THE TYPICAL ENCOUNTERED (HETEROPHILIC ANTIBODIES, RHEUMATOID FACTORS, ANTI-TROPONIN AUTOANTIBODIES). THE LACK OF ADDITIONAL SAMPLES DID NOT ALLOW BIOMÉRIEUX TO PURSUE FURTHER INVESTIGATION. POTENTIAL INTERFERENCES WITH HSTNI REAGENTS LEADING TO FALSE POSITIVE RESULTS IN THE FIELD HAVE ALREADY BEEN DESCRIBED THROUGH MANY PUBLICATIONS AND CONCERNED DIFFERENT ASSAYS IN THE MARKET. THE VIDAS® HSTNI KIT IS UP TO DATE REGARDING FALSE POSITIVE RESULTS OF SIMILAR INTERFERENCES THAT WERE DESCRIBED IN NUMEROUS PUBLICATIONS AND FOUND IN COMPETING TECHNIQUES. AS A REMINDER, IN 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." THE VIDAS® HSTNI LOT 1005302910/180126-0, IS WITHIN CURRENT ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX THAT THEY HAVE OBSERVED NON-REPEATABLE FALSELY OVER ESTIMATED RESULTS WHEN USING VIDAS® HS TROPONIN I (REFERENCE (B)(4)). THE CUSTOMER REPORTED THAT THE PHYSICIAN REQUIRED A TROPONIN TEST BECAUSE THE PATIENT COMPLAINED OF ANTERIOR CARDIAC PROBLEMS AND CHEST PAIN. THE SAMPLE WAS DRAWN AT THE LABORATORY ON (B)(6) 2017. THE RESULT WAS POSITIVE (33.7NG/L). A SECOND TEST WAS PERFORMED ON THE SAME SAMPLE AN HOUR LATER AND THE RESULT WAS POSITIVE (30.1 NG/L). THE RESULT WAS TRANSMITTED TO THE PHYSICIAN. FOLLOWING THE RESULT, THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT AT THE HOSPITAL WHERE A CORONARY ANGIOGRAPHY WAS PERFORMED. THE TEST CONCLUDED THAT THE PATIENT WAS NOT SUFFERING FROM A MYOCARDIAL INFARCTION. A TROPONIN TEST BY AN UNKNOWN METHOD WAS PERFORMED AT THE HOSPITAL AND THE RESULT WAS NEGATIVE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340531 VIDAS® HS TROPONIN I VIDAS® HS TROPONIN I MMI BIOMERIEUX SA 415386 1005302910

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization