BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 16571776 · Received March 20, 2023

    Report

    Report Number
    1823260-2023-00887
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    February 14, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    SECTION H6 WAS UPDATED. CALIBRATION AND QC WERE ACCEPTABLE ON THE DAY OF TESTING. ALARM TRACE FROM (B)(6) 2023 SHOWED 4 ALARMS RELATED TO SAMPLE QUALITY ISSUE: 4X ABNORMAL SAMPLE ASPIRATION, I.E. SAMPLE CLOT OR INADEQUATE SAMPLE VOLUME WAS DETECTED DURING ASPIRATION. THE FULL REPORT FOR THE INSTRUMENT CHECK WAS REQUESTED BUT WAS NOT PROVIDED. THE PROVIDED PHOTO OF THE AFFECTED SAMPLE SHOWED THE GEL LAYER IS REDDISH SPOTTED AND UNEVEN (GEL SURFACE SHOULD BE HORIZONTAL) WHICH MIGHT AN INDICATION OF AN INSUFFICIENT SAMPLE QUALITY. FROM THE DATA PROVIDED, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. NO PRODUCT PROBLEM WAS FOUND.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH THE ELECSYS TROPONIN T HS ASSAY ON COBAS 8000 E602 MODULE SERIAL NUMBER (B)(4). THE FOLLOWING TROPONIN T HS RESULTS WERE REPORTED: INITIAL RESULT ON (B)(6)2023 AT 5:23 PM: 459.9 NG/L, RE-RUN IN ANOTHER LABORATORY ON 2 DIFFERENT SAMPLES: 10 NG/L, RE-RUN ON COBAS E602 ON (B)(6)2022 AT 11:43 AM: 11 NG/L, AND RE-RUN ON ANOTHER COBAS E602 ON (B)(6)2022 AT 12:08 PM: 11 NG/L THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371303 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA 614921

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male