BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TROPONIN I ULTRA

    MDR report key: 7734984 · Received July 31, 2018

    Report

    Report Number
    3002769706-2018-00122
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    May 20, 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 (B)(4), LOT 1006309100). THE CUSTOMER TESTED SERUM FROM THREE 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: SAMPLE (B)(6): SAMPLE TESTING BEGAN (B)(6) 2018 AT 13:36:26 WITH RESULT : 0.04 UG/L. SAMPLE TESTING BEGAN (B)(6) 2018 AT 14:02:44 WITH RESULT : < 0.01 UG/L. SAMPLE (B)(6): SAMPLE TESTING BEGAN (B)(6) 2018 AT 14:59:58 WITH RESULT : 0.09 UG/L. SAMPLE TESTING BEGAN (B)(6) 2018 AT 15:37:42 WITH RESULT : < 0.01 UG/L. SAMPLE (B)(6): SAMPLE TESTING BEGAN (B)(6) 2018 AT 07:55:57 WITH RESULT : 0.07 UG/L. SAMPLE TESTING BEGAN (B)(6) 2018 AT 08:28:11 WITH RESULT : < 0.01 UG/L. EACH SAMPLE WAS CENTRIFUGED AT A SPEED OF 1200 RPM/MINS FOR 10 MINUTES. THE CUSTOMER NO LONGER HAS THE SAMPLES TO SUBMIT FOR EVALUATION. THE CUSTOMER REPORTED THAT NO PATIENT RESULTS WERE AFFECTED, NO WRONG RESULTS WERE REPORTED TO A PHYSICIAN, AND THERE WAS NO PATIENT HARMED OR TREATED INCORRECTLY. 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
    577790 VIDAS® TROPONIN I ULTRA VIDAS® TROPONIN I ULTRA MMI BIOMERIEUX SA 1006309100

    Patients

    Seq Age Sex Outcome Treatment
    1