BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TROPONIN I ULTRA

    MDR report key: 7740840 · Received August 1, 2018

    Report

    Report Number
    3002769706-2018-00133
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Date of Event
    June 21, 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 30448, 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 THREE SERUM SAMPLES FROM ONE PATIENT. THE FIRST SAMPLE (SAMPLE ID (B)(6)) RESULTED AS POSITIVE AT 3.17 UG/L. THE SECOND SAMPLE (SAMPLE ID (B)(6)) WAS TESTED AT 20:40 AND RESULTED AS NEGATIVE AT <0.01 UG/L. THE RESPONSIBLE ED PHYSICIAN CALLED THE LAB QUESTIONING THE RESULTS. THE LAB RETESTED THE FIRST SAMPLE (VIA MANUAL AND AUTOMATIC MODE) AND SECOND SAMPLE (VIA MANUAL MODE). BOTH SAMPLES OBTAINED NEGATIVE RESULTS. A NEW SAMPLE WAS COLLECTED (SAMPLE ID (B)(6)) AND TESTED NEGATIVE AS WELL. THE SAMPLES AND RESULTS ARE AS FOLLOWS: SAMPLE (B)(6): SAMPLE TESTING BEGAN (B)(6) 2018 AT 19:18:44 WITH RESULT : 3.17 UG/L. SAMPLE RETESTED IN MANUAL AND AUTOMATIC MODE (B)(6) 2018 WITH EACH RESULT : < 0.01 UG/L. SAMPLE (B)(6): SAMPLE TESTING BEGAN (B)(6) 2018 AT 20:40:53 WITH RESULT : < 0.01 UG/L. SAMPLE (B)(6): SAMPLE TESTING BEGAN (B)(6) 2018 WITH RESULT : < 0.01 UG/L. EACH SAMPLE WAS CENTRIFUGED AT A SPEED OF 3500 RPM/MIN (2330G) FOR FIVE MINUTES. 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 WAS REPORTED TO A PHYSICIAN. THE TIME BETWEEN THE FALSE POSITIVE TEST AND NEGATIVE RESULTS WAS REPORTED TO CAUSE 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
    580749 VIDAS® TROPONIN I ULTRA VIDAS® TROPONIN I ULTRA MMI BIOMERIEUX SA 1006309100

    Patients

    Seq Age Sex Outcome Treatment
    1