BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN I STAT IMMUNOASSAY

    MDR report key: 8781800 · Received July 11, 2019

    Report

    Report Number
    1823260-2019-02538
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 12, 2019
    Report Date
    September 3, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K082699
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROVIDED QC DATA IS WITHIN ACCEPTABLE RANGE. A SERUM FRACTIONATION OF THE PROVIDED SAMPLE DETERMINED AN INTERFERENCE CAUSED BY A HIGH MOLECULAR WEIGHT COMPONENT, MOST LIKELY IGM AND HUMAN ANTI-MOUSE ANTIBODY. THIS TYPE OF INTERFERENCE IS ADDRESSED IN THE PRODUCT LABELING: "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO IMMUNOLOGICAL COMPONENTS, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN."

    Additional Manufacturer Narrative · 1

    THREE SAMPLES FROM THE PATIENT WERE SUBMITTED FOR INVESTIGATION. THE SAMPLES WERE RUN WITH TROPONIN I STAT REAGENT LOT 365747 ON AN E601 MODULE AT THE INVESTIGATION SITE. THE CUSTOMER'S POSITIVE TROPONIN I STAT RESULTS WERE REPRODUCED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT TESTED FOR ELECSYS TROPONIN I STAT IMMUNOASSAY (TROPONIN I STAT) ON A COBAS 6000 E 601 MODULE COMPARED TO THE ABBOTT ISTAT METHOD. THE INITIAL RESULT FROM THE E601 MODULE WITH A RESULT OF 1.13 NG/ML. THE SAMPLE WAS RUN BY THE ISTAT METHOD IN THE ER WITH A RESULT OF 0.00 NG/ML. THESE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE E601 RESULTS AND A CARDIAC STRESS TEST (EXERCISE) WAS ADMINISTERED. THE PATIENT HAD NO KNOWN CARDIAC SYMPTOMS. THE REPEAT RESULT ON THE E601 MODULE WAS 0.96 NG/ML. THE REPEAT RESULT ON THE ISTAT WAS 0.00 NG/ML. THE PATIENT WAS TESTED AGAIN BY THE ISTAT METHOD WITH A RESULT OF 0.01 NG/ML. IT IS NOT KNOWN IF THIS RESULT IS FROM THE SAME SAMPLE OR IF THIS WAS A NEW SAMPLE. ON (B)(6) 2019 THE PATIENT WAS REDRAWN AND THE RESULT ON THE E601 MODULE WAS 0.95 NG/ML. THE PATIENT WAS REDRAWN AGAIN AND THE RESULT FROM THE E601 MODULE WAS 0.94 NG/ML. THE RESULTS FROM THE STRESS TEST WERE NEGATIVE SO THE PATIENT WAS DISCHARGED. THE PATIENT WAS NOT ADVERSELY AFFECTED DUE TO THE CARDIAC STRESS TEST AND NO FURTHER TREATMENT WAS REQUIRED. THE CUSTOMER SUSPECTS AN INTERFERENCE IN THE PATIENT SAMPLE AFFECTING THE RESULTS. THE E601 MODULE SERIAL NUMBER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574140 ELECSYS TROPONIN I STAT IMMUNOASSAY IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA 36574701

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR ADDEROL - 1X/DAY| ADDEROL - 1X/DAY