BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TROPONIN I ULTRA

    MDR report key: 7737040 · Received July 31, 2018

    Report

    Report Number
    3002769706-2018-00124
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    May 26, 2018
    Report Date
    August 29, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    MMI
    PMA / PMN Number
    K063243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN TAIWAN NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE RESULTS WHEN TESTING WITH VIDAS® TROPONIN I ULTRA (REF: (B)(4), LOT: 1006309100). AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. QUALITY CONTROL RECORDS: NO NON-CONFORMITY OR CAPA LINKED TO THE CUSTOMER'S COMPLAINT IS RECORDED ON VIDAS TROPONIN I ULTRA (TNIU). ANALYSIS OF THE BATCH HISTORY RECORDS: THERE WAS NO ANOMALY DURING THE MANUFACTURING AND CONTROL PROCESSES. STUDY OF INTERNAL SAMPLES CONTROL CHARTS: AT LEAST FOUR (4) INTERNAL SAMPLES ON FIVE (5) VIDAS TNIU LOTS INCLUDING LOT: 1006309100 / 190212-0 : ALL RESULTS ARE WITHIN THE EXPECTED SPECIFICATIONS, AND THE INCRIMINATED LOT IS WITHIN THE TREND OF THE PARAMETER. TESTS PERFORMED: REPEATABILITY TESTING WAS PERFORMED ON BLOOD DONOR (EFS POOL) SAMPLES. THE TEST WAS REPEATED 30 TIMES AND ALL ARE 0.01 G/L. NO OUTLIER WAS OBSERVED; THE CUSTOMER ANOMALY WAS NOT REPRODUCED. CONCLUSION ACCORDING TO ALL INFORMATION ABOVE, THE PERFORMANCE OF VIDAS TNIU BATCH :1006309100 / 190212-0 IS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE RESULTS WHEN TESTING WITH VIDAS® TROPONIN I ULTRA (REF 30448, LOT 1006309100). THE CUSTOMER TESTED SERUM FROM SIX DIFFERENT PATIENTS. FOR EACH ONE, THE FIRST RESULT WAS POSITIVE AND WHEN RETESTED, THE RESULT OBTAINED WAS <0.01 UG/L (NEGATIVE). THE SAMPLES AND RESULTS ARE AS FOLLOWS: (B)(6). EACH SAMPLE WAS CENTRIFUGED AT A SPEED OF 12,000 RPM/MIN FOR ONE MINUTE. THE CUSTOMER NO LONGER HAS THE SAMPLES TO SUBMIT FOR EVALUATION. THE CUSTOMER REPORTED THAT NO PATIENT RESULTS WERE AFFECTED, AND THERE WAS NO PATIENT HARMED OR TREATED INCORRECTLY.. THE WRONG RESULT OF SAMPLE (B)(6) WAS REPORTED TO PHYSICIAN. FOR THE OTHER SAMPLES, NO WRONG RESULTS WERE REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED A DELAY OF APPROXIMATELY 1-2 HOURS. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577419 VIDAS® TROPONIN I ULTRA VIDAS® TROPONIN I ULTRA MMI BIOMERIEUX SA 1006309100

    Patients

    Seq Age Sex Outcome Treatment
    1