BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIDAS® HS TROPONIN I

    MDR report key: 6900246 · Received September 28, 2017

    Report

    Report Number
    3002769706-2017-00286
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    September 2, 2017
    Report Date
    October 30, 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

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF REPEATABLE FALSE POSITIVE RESULTS IN ASSOCIATION WITH VIDAS® HIGH SENSITIVE (HS) TROPONIN (TN) I (REF. 415386) - LOT 1005783570 / 180720-0. AFTER TWO FALSELY ELEVATED HS TROPONIN I RESULTS, A (B)(6) YEAR-OLD MAN WAS SENT TO THE EMERGENCY ROOM. THE INITIAL SAMPLE WAS LATER CONFIRMED NEGATIVE WITH THE ROCHE TECHNIQUE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. RECORDS ANALYSIS: THE PRODUCT QUALITY LABORATORY HAS STUDIED THE CONTROL CARDS OF 16 BATCHES OF VIDAS® TNHS KIT : LOT 1005783570 / 180720-0 IS IN THE TREND ANALYSIS COMPARED TO THE OTHER BATCHES. THE QUALITY PRODUCT LABORATORY HAS TESTED 5 INTERNAL SAMPLES : ALL THE RESULTS WERE WITHIN THEIR SPECIFICATION. SO THE VIDAS® TNHS LOT 1005783570 / 180720-0 IS WITHIN ITS ACCEPTANCE CRITERIA. THE CUSTOMER'S SAMPLE WAS FORWARDED TO THE R&D DEPARTMENT FOR FURTHER INVESTIGATIONS. THE SAMPLE WAS TESTED ON : VIDAS TNI REF. 30448. VIDAS TNHS REF. 415386, BATCH 180602-0 (BATCH NUMBER DIFFERENT THAN THE ONE MENTIONED BY THE CUSTOMER). WITH VIDAS® TNI REF. 30448, THE RESULT WAS POSITIVE 0.81¿G/L. WITH VIDAS® TNHS REF. 415386, THE RESULT WAS 1478.0 NG/L. 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. AN HBT TEST (HETEROPHILIC BLOCKING TUBE) WAS PERFORMED. THE RESULTS IN TNIU AND TNHS WERE POSITIVE. THIS IS NOT AN INTERFERENCE DUE TO HETEROPHILIC ANTIBODIES. UNFORTUNATELY, THE LACK OF VOLUME DID NOT ALLOW US TO IDENTIFY THE NATURE OF THIS INTERFERENCE. HOWEVER AS THE VIDAS® TNHS BATCH NUMBER USED BY QUALITY PRODUCT LABORATORY IS DIFFERENT THAN THE CUSTOMER'S BATCH, WE CAN EXCLUDE AN INTERFERENCE LINKED TO THE BATCH. VIDAS® TNHS LOT 1005783570 / 180720-0 PERFORMED WITHIN ITS ACCEPTANCE CRITERIA. THE PATIENT SAMPLE HAS INTERFERENCE WITH THE VIDAS® TNHS PARAMETER. 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."

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(4) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE RESULTS IN ASSOCIATION WITH VIDAS® HIGH SENSITIVE TROPONIN I (REF. 415386) - LOT 1005783570. THOUGH THE VIDAS® HIGH SENSITIVE TROPONIN I ASSAY (REF. 415386) IS NOT REGISTERED IN THE UNITED STATES, A SIMILAR PRODUCT (VIDAS® TROPONIN I ULTRA ASSAY, REF. 30448) IS REGISTERED. THE PATIENT IS A (B)(6) MAN WITH CHEST PAIN. HIS PHYSICIAN HAD ORDERED THE HIGH SENSITIVE TROPONIN I TESTING, WHICH WAS COLLECTED AND TESTED ON (B)(6) 2017. THE FIRST RESULT WAS POSITIVE AT 1274.4NG/L. IT WAS RETESTED, AND FOUND POSITIVE AGAIN AT 1247.1NG/L. THE RESULT WAS REPORTED TO THE PHYSICIAN, AND THE PATIENT WAS SENT TO THE HOSPITAL EMERGENCY ROOM. THERE, HE HAD ANOTHER TROPONIN TEST (THE TECHNIQUE USED IS NOT KNOWN), WHICH WAS NEGATIVE. THE PATIENT WENT HOME AS A RESULT OF THE NEGATIVE RESULT OBTAINED IN THE HOSPITAL. PER THE CUSTOMER, HE RECEIVED NO TREATMENT AND HAD NO CLINICAL SIGNS OF INFARCTION. ON (B)(6) 2017, THE CUSTOMER SENT THE PATIENT SAMPLES DRAWN ON (B)(6) 2017 TO ANOTHER LABORATORY. THE RESULTS HAVE BEEN CONFIRMED NEGATIVE WITH THE ROCHE TECHNIQUE. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680821 VIDAS® HS TROPONIN I VIDAS® HS TROPONIN I MMI BIOMERIEUX, SA 1005783570

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization