BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE CARDIAC, TROPONIN T QUANTITATIVE

    MDR report key: 4305526 · Received December 8, 2014

    Report

    Report Number
    1823260-2014-09684
    Event Type
    Malfunction
    Date Received
    December 8, 2014
    Date of Event
    November 15, 2014
    Report Date
    December 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K000784
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT WHO WAS TESTED FOR TROPONIN T QUANTITATIVE (TNT). THE PATIENT WAS INITIALLY TESTED ON A COBAS H232 ANALYZER IN THE AMBULANCE AND THE TNT RESULT WAS "50 - 100.000" NG/L. THE PATIENT WAS BROUGHT TO THE HOSPITAL WHERE HE WAS TESTED USING COBAS 6000 METHODOLOGY AND THE TNT RESULT WAS <10 NG/L. THE <10 NG/L RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT HAD MASSIVE CHEST PAIN DURING THE TIME OF THE EVENT. THE PATIENT HAD BEEN HAVING MILDER PAIN IN THE CHEST AND BACK AREA, BUT THE PAIN SUDDENLY INCREASED. UPON EXAMINATION AT THE HOSPITAL, THE PATIENT SHOWED MILD PAINS. THE PATIENT IS "HEMODYNAMIC STABILE" AS SHOWN BY ECG. THE PATIENT RECEIVED AN "ACUTE KAG" PROCEDURE AND RECEIVED PRETREATMENT FOR "PCI" BASED ON THE ERRONEOUS RESULT. THE PATIENT RECEIVED A MAGNYL TABLET, A BRILIQUE TABLET, AND IV HEPARIN. THE PATIENT WAS INCLUDED IN A "NONSTEMI" STUDY. THE PATIENT'S CURRENT CONDITION IS "STATUS QUO". THE PATIENT WAS NOT HARMED BY AN ACTIONS TAKEN. RETENTION MATERIALS WERE INVESTIGATED AND THE RESULTS FROM RETENTION TESTING MEET REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790366 ROCHE CARDIAC, TROPONIN T QUANTITATIVE IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA 28167515

    Patients

    Seq Age Sex Outcome Treatment
    1 039 YR