BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® HS TROPONIN I

    MDR report key: 6894773 · Received September 26, 2017

    Report

    Report Number
    3002769706-2017-00287
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    August 29, 2017
    Report Date
    October 27, 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

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: A DISCREPANCY OR ANOMALY WAS NOT OBSERVED DURING A REVIEW OF THE DEVICE HISTORY RECORD. THE PRODUCT QUALITY LABORATORY HAS STUDIED THE CONTROL CARDS OF SIXTEEN 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 FIVE INTERNAL SAMPLES: ALL THE RESULTS WERE WITHIN SPECIFICATION. ADDITIONAL TESTING INCLUDED TEN SERA SAMPLES WITH VIDAS® TNHS LOT 1005783570 / 180720-0. THE RESULTS WERE REPEATABLE (RESULTS ARE BETWEEN <1.5 NG/L AND 1.7 NG/L), NO ANOMALY WAS FOUND ON THE REPEATABILITY ON THE BATCH VIDAS® TNHS LOT 1005783570 / 180720-0. THE PRODUCT QUALITY LABORATORY DID NOT REPRODUCE THE CUSTOMER'S ANOMALY. THE PRODUCT QUALITY LABORATORY HAS CALCULATED THE OCCURRENCE OF THE OUTLIER ANOMALY SINCE APRIL 2016 TO OCTOBER 2017 COMPARED TO THE NUMBER OF TESTS RELEASED AT BIOMERIEUX FOR THE VIDAS® TNSH PARAMETER (REF 415386): NO UPWARD TREND IN CLAIMS FOR REPRODUCIBILITY PROBLEM SINCE APRIL 2016 WITH A MAXIMUM OCCURRENCE AT 0.003%. THE OCCURRENCE FOR THE LOT VIDAS® TNSH 1005783570 / 180720-0 IS 0.001%. THE BATCH VIDAS® TNHS 1005783570 / 180720-0 REACHED THE EXPECTED PERFORMANCE. IT IS DESCRIBED IN THE LITERATURE THAT OUTLIERS CAN OCCUR IN ALL THE HIGH SENSITIVE TROPONIN I ASSAY USING EIA METHOD. THE MEDICAL IMPACT OF THE OUTLIERS HAS BEEN ASSESSED IN VIDAS® THNS WITH THE HELP OF EXTERNAL EXPERTS AND MEDICAL AFFAIRS DEPARTMENT. THE CONCLUSION IS THAT EVEN AT A RATE OF 1% CRITICAL OUTLIERS (RESULTING IN 10 ADDITIONAL FALSE POSITIVES PER 1000 PATIENTS TESTED), THE IMPACT ON THE SPECIFICITY AND THE PREDICTIVE POSITIVE VALUE IS ACCEPTABLE. THE MOST IMPORTANT CLINICAL PERFORMANCE IS THE NEGATIVE PREDICTIVE VALUE, AND IT IS NOT IMPACTED BY CRITICAL OUTLIERS. AN INTERNAL INVESTIGATION HAS CONFIRMED THE PERCENTAGE OF OUTLIERS REMAINS SIGNIFICANTLY BELOW OUR SPECIFICATION IS 0.001 % (CRITERIA ESTABLISHED DURING DESIGN PHASE WAS < 1%).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSELY OVER-ESTIMATED RESULTS WHEN USING THE PRODUCT: VIDAS® HIGH SENSITIVE TROPONIN I (REF. 415386) - LOT 1005783570. THOUGH THE VIDAS® HIGH SENSITIVE TROPONIN I ASSAY IS NOT REGISTERED IN THE UNITED STATES, A SIMILAR PRODUCT (VIDAS® TROPONIN I ULTRA ASSAY, REF. 30448) IS REGISTERED. A (B)(6) MAN WAS ADMITTED TO THE HOSPITAL FOR PAIN. ON (B)(6) 2017, TWO SAMPLE TUBES WERE COLLECTED FROM THIS PATIENT. THE FIRST TUBE HAD A POSITIVE HS TROPONIN I RESULT OF 278.3NG / L. THE SECOND TUBE WAS TESTED WITH A NEGATIVE RESULT OF <1.5 NG / L. THE FIRST TUBE WAS RETESTED AND GAVE A NEGATIVE RESULT OF 1.6NG / L. THE DELAY BETWEEN SAMPLING TIME AND THE LAST TEST WAS 1 HOUR, 40 MINUTES PER THE CUSTOMER. THE PATIENT RETURNED HOME. THE PATIENT WAS NOT HARMED OR INCORRECTLY TREATED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675100 VIDAS® HS TROPONIN I VIDAS® HS TROPONIN I MMI BIOMERIEUX, SA 1005783570

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR