BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 801 IMMUNOASSAY ANALYZER

    MDR report key: 21168132 · Received January 16, 2025

    Report

    Report Number
    1823260-2025-00163
    Event Type
    Malfunction
    Date Received
    January 16, 2025
    Date of Event
    December 19, 2024
    Report Date
    February 7, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630946198
    PMA / PMN Number
    K162606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PTH REAGENT LOT NUMBER WAS 801714 WITH AN EXPIRATION DATE OF 30-SEP-2025.

    Additional Manufacturer Narrative · 0

    QC WAS ACCEPTABLE. CALIBRATION DATA FROM 21-DEC-2024 WAS UNACCEPTABLE. NO CALIBRATION DATA WAS PROVIDED FROM BEFORE THE EVENT. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. BEFORE THE SERVICE VISIT, THE CUSTOMER REMOVED THE INCORRECT REAGENT BOTTLE AND LOADED A NEW PRECLEAN SYSTEM REAGENT. THE FIELD SERVICE ENGINEER (FSE) PERFORMED SIPPER AIR PURGES, SYSTEM AIR PURGES, SYSTEM PRIMES, REAGENT PRIMES, AND MEASURING CELL CONDITIONING. THE FSE OBSERVED THE INSTRUMENT OPERATING NORMALLY. THE CUSTOMER HAD NO FURTHER ISSUES. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO AN INCORRECT MAINTENANCE PROCEDURE PERFORMED BY THE CUSTOMER.

    Description of Event or Problem · 0

    THE CUSTOMER STATED A TECHNICIAN PLACED A DILUENT REAGENT IN THE PLACE OF THE PRECLEAN SYSTEM REAGENT ON A COBAS E 801 IMMUNOASSAY ANALYZER. THE CUSTOMER THINKS THIS MAY HAVE BEEN DONE ON THE MORNING OF (B)(6) 2024, HOWEVER, THIS COULD NOT BE CONFIRMED. THE CUSTOMER REPEATED 473 PATIENT SAMPLES ON A DIFFERENT E801 ANALYZER. THE RESULTS FOR 3 PATIENTS WERE CORRECTED. THE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS PTH (PTH) WERE DISCREPANT. THE INITIAL PTH RESULT WAS 60.6 PG/ML. THE REPEAT RESULT WAS 41.8 PG/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792014 COBAS E 801 IMMUNOASSAY ANALYZER CLINICAL IMMUNOASSAY ANALYZER JJE ROCHE DIAGNOSTICS E801 04015630946198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown