BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 801 ANALYTICAL UNIT

    MDR report key: 19923002 · Received August 6, 2024

    Report

    Report Number
    1823260-2024-02284
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 23, 2024
    Report Date
    August 6, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESTRADIOL REAGENT LOT NUMBER WAS 791017. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER DETERMINED THAT THE DEGASSER TRAP WAS COMPACTED AND THERE WAS A DAMAGED MEASURING CELL NOZZLE. THE DEGASSER TRAP AND NOZZLE WERE REPLACED. THE ISSUE WAS RESOLVED AFTER THESE ACTIONS. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH ELECSYS ESTRADIOL III ON A COBAS E 801 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN AN ESTRADIOL VALUE OF < 5.00 NG/L. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 13.4 NG/L AND 15.7 NG/L. THE SECOND SAMPLE INITIALLY RESULTED IN AN ESTRADIOL VALUE OF < 5.00 NG/L ON (B)(6) 2024. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN A VALUE OF 42.2 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561269 COBAS E 801 ANALYTICAL UNIT IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown