BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TROPONIN I ULTRA

    MDR report key: 5477511 · Received March 3, 2016

    Report

    Report Number
    3002769706-2016-00042
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Report Date
    February 26, 2016
    Manufacturer
    BIOMERIEUX SA
    Product Code
    MMI
    PMA / PMN Number
    K063243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A FALSE POSITIVE RESULT INVOLVING VIDAS® TROPONIN I ULTRA LOT 1004203640/ 160724-0. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: NO OTHER COMPLAINTS FOR VIDAS® TROPONIN I ULTRA LOT 1004203640/ 160724-0. NO CAPA OR NONCONFORMITY LINKED WITH VIDAS® TROPONIN I ULTRA LOT 1004203640/ 160724-0. TESTS PERFORMED ON FOUR (4) INTERNAL SAMPLES FROM QUALITY CONTROL LABORATORY AND ONE EFS SAMPLE WITH VIDAS TROPONIN I ULTRA LOT 1004203640/ 160724-0 ON VIDAS® PC . RESULTS- THE FOUR (4) INTERNAL SAMPLES HAD RESULTS THAT WERE FOUND IN THEIR EXPECTED RANGES AND ONE (1) EFS SAMPLE WAS TESTED 8 TIMES, THE RESULTS WERE < 0.01 MICRO G / L EACH TIME. CONCLUSION- ABSENCE OF ANOMALY WITH VIDAS® TROPONIN I ULTRA LOT 1004203640/ 167024-0 CONFIRMED. PRODUCT PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED NON REPETITIVE RESULTS WHILE USING THE; VIDAS TROPONIN I ULTRA REF (B)(4) LOT 1004203640. A RESULT OF 0.5UG/L WAS INITIALLY RECEIVED. THE DOCTOR REPEATED A SECOND TEST ON THE PATIENT IN THE EMERGENCY ROOM WITH A RESULT OF <0.01 UG/L. THE PATIENT WAS TESTED A THIRD TIME WITH A HEPARIN TUBE AND A SST TUBE WHICH RETURNED THE SAME RESULTS OF; <0.01 UG/L FOR EACH TUBE. A FINAL TEST WAS THEN RUN ON THE ORIGINAL TUBE TWICE WITH THE RETURN OF A FALSE RESULT OF; <0.01 UG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135002 VIDAS® TROPONIN I ULTRA VIDAS® TROPONIN I ULTRA MMI BIOMERIEUX SA 1004203640

    Patients

    Seq Age Sex Outcome Treatment
    1