BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 20668220 · Received November 12, 2024

    Report

    Report Number
    1823260-2024-03283
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 19, 2024
    Report Date
    December 6, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630946198
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TROPONIN T REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE MEASURING CELLS. THE SYSTEM WAS CONFIRMED TO BE OPERATING WITHIN SPECIFICATION. FOLLOWING THE SERVICE VISIT, THE CUSTOMER CONTINUED TO HAVE QC ISSUES. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    IN ADDITION TO REPLACING THE MEASURING CELLS, THE FIELD SERVICE ENGINEER (FSE) REPLACED PINCH VALVE TUBES, A SIPPER NOZZLE, AND A PINCH VALVE. SINCE SEVERAL COMPONENTS WERE REPLACED, THE SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF QC ISSUES ON A COBAS 8000 E 801 MODULE. AN UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE REPEATED FOR TROPONIN T AND DIFFERENCES WERE OBSERVED. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FOR (B)(4) PATIENT SAMPLES TESTED FOR TROPONIN T. PATIENT (B)(4) INITIAL RESULT WAS 562 NG/L. THE REPEAT RESULT WAS 446 NG/L. PATIENT (B)(4) INITIAL RESULT WAS 104 NG/L. THE REPEAT RESULT WAS 80 NG/L. PATIENT (B)(4) INITIAL RESULT WAS 19.7 NG/L. THE REPEAT RESULT WAS 11 NG/L. PATIENT (B)(4) INITIAL RESULT WAS 30 NG/L. THE REPEAT RESULT WAS 18.3 NG/L. PATIENT (B)(4) INITIAL RESULT WAS 35.9 NG/L. THE REPEAT RESULT WAS 23.5 NG/L. PATIENT (B)(4) INITIAL RESULT WAS 715 NG/L. THE REPEAT RESULT WAS 539 NG/L. PATIENT (B)(4) INITIAL RESULT WAS 12.3 NG/L. THE REPEAT RESULT WAS 6.17 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643856 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801 04015630946198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown