BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 20779216 · Received November 26, 2024

    Report

    Report Number
    1823260-2024-03431
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    November 3, 2024
    Report Date
    December 13, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630946198
    PMA / PMN Number
    K060373
    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 FIELD SERVICE ENGINEER (FSE) DECONTAMINATED THE MODULE; REPLACED THE SYRINGE SEAL AND PREPARED THE MEASURING CELLS (MC). HE PERFORMED AN INSTRUMENT CHECK WITH SUCCESSFUL RESULTS. NO FURTHER ISSUES WERE REPORTED AFTER SERVICE.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 791017. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) PERFORMED PREVENTIVE MAINTENANCE ON THE MODULE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS ESTRADIOL III RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 MODULE. THE INITIAL RESULT FROM LINE 1 WAS 783 PG/ML. THE FIRST REPEAT RESULT FROM LINE 2 WAS 57.800 PG/ML. THE SECOND REPEAT RESULT FROM LINE 1 WAS <55 PG/ML WITH A DATA FLAG. THE THIRD REPEAT RESULT FROM LINE 2 WAS 58.800 PG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2576608 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801 04015630946198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown