BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 801 ANALYTICAL UNIT

    MDR report key: 21398632 · Received February 18, 2025

    Report

    Report Number
    1823260-2025-00457
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 14, 2025
    Report Date
    February 17, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K162606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 792314. THE EXPIRATION DATE WAS NOT PROVIDED. THE CALIBRATION AND QC WERE ACCEPTABLE. THE ALARM TRACE SHOWED ABNORMAL ASPIRATION (SAMPLE PROBE), ABNORMAL ASPIRATION (SAMPLE PROBE A), AND ABNORMAL ASPIRATION ALARMS. THE FIELD SERVICE REPRESENTATIVE FOUND THE PREWASH NOZZLES WERE BENT. HE REPLACED THE PREWASH NOZZLES, PERFORMED ADJUSTMENTS, AND CLEANED THE ASPIRATION LINE. HE PERFORMED CHECKS AND TESTS WITH ACCEPTABLE RESULTS. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+B RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 5.4 MIU/ML. ON (B)(6) 2025 THE REPEATED RESULT WAS 249 MIU/ML. THE SAMPLE WAS REPEATED AS THE INITIAL RESULT WAS QUESTIONED BY THE PHYSICIAN. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294462 COBAS E 801 ANALYTICAL UNIT IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female