BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 16487168 · Received March 6, 2023

    Report

    Report Number
    1823260-2023-00682
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    February 2, 2023
    Report Date
    April 25, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961500
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALIBRATION AND QC WERE BOTH ACCEPTABLE ON THE DAY OF THE EVENT AND ONWARDS. IT IS UNKNOWN IF A RACK ADAPTER WAS USED FOR THE 13 X 75 MM SAMPLE TUBE. THE CLOTTING TIME WAS APPROXIMATELY 1 HOUR. THE CENTRIFUGATION SPEED WAS 3190 RPM AND THE CENTRIFUGATION TIME WAS 10 MINUTES. BASED ON THE LIMITED INFORMATION PROVIDED, A LOCAL PRE-ANALYTICAL ISSUE CANNOT BE EXCLUDED. THE ALARM TRACE FROM (B)(6) 2023 WAS PROVIDED. AS THE QUESTIONABLE RESULT WAS MEASURED ON (B)(6) 2023, THE RELEVANT TIME FRAME WAS NOT DISPLAYED. THE PROVIDED ALARM TRACE DID NOT INDICATE ANY ISSUES. BASED ON THE PROVIDED DATA, A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS TROPONIN T HS ASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 E 601 MODULE WITH SERIAL NUMBER 2409-13. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. A NEW SAMPLE FROM THE SAME PATIENT WAS SENT 4 HOURS LATER AND A DIFFERENT RESULT WAS OBTAINED FOR THIS PATIENT SAMPLE FROM THEIR OTHER MODULE. ON (B)(6) 2023: AT 3:12 PM, THE INITIAL RESULT OF THE INITIAL SAMPLE FROM THE MODULE WAS 57.25 PG/ML. AT 7:33 PM, THE REPEAT RESULT OF THE INITIAL SAMPLE FROM THE OTHER MODULE WAS 4.05 PG/ML. THE RESULT OF THE NEW SAMPLE FROM THE OTHER MODULE WAS 5 PG/ML. ON (B)(6) 2023: AT 10:10 AM, THE REPEAT RESULT OF THE INITIAL SAMPLE FROM THE MODULE WAS 5.44 PG/ML. AT 10:47 AM, THE REPEAT RESULT OF THE INITIAL SAMPLE FROM THE MODULE WAS 7.67 PG/ML. AT 1:33 PM, THE REPEAT RESULT OF THE INITIAL SAMPLE FROM THE MODULE WAS 10.56 PG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707582 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA 614921

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown