BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (DISK SYSTEM)

    MDR report key: 18830379 · Received March 4, 2024

    Report

    Report Number
    1823260-2024-00644
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    February 5, 2024
    Report Date
    March 28, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630937103
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS D1, D2, D2B, D4, G1 AND G4 WERE UPDATED. THE SAMPLES WERE PLASMA SAMPLES. THE CALIBRATION WAS LAST PERFORMED ON 01-FEB-2024 AND IT WAS ACCEPTABLE. A GENERAL REAGENT ISSUE CAN BE EXCLUDED AS QC WAS WITHIN THE RANGES. THE SERVICE ACTIONS (REPLACING THE MEASURING CELL AND THE DETECTION UNIT TUBING) RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT.

    Additional Manufacturer Narrative · 0

    THE PTH STAT REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE SERIAL NUMBER OF THE FIRST COBAS E411 IMMUNOASSAY ANALYZER WAS (B)(6). QC WAS REPORTEDLY ACCEPTABLE ON THE MORNING OF THE EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE MEASURING CELL AND THE DETECTION UNIT TUBING. THE FSE PERFORMED A SYSTEM VOLUME CHECK, HIGH VOLTAGE ADJUSTMENT, AN INSTRUMENT CHECK, AND A BLANK CELL CALIBRATION AND THEY WERE ALL SUCCESSFUL.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS PARATHYROID HORMONE (PTH) STAT ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER WHEN COMPARED TO A SECOND E411 IMMUNOASSAY ANALYZER. SAMPLE 1: THE INITIAL RESULT RUN ON THE FIRST COBAS E411 IMMUNOASSAY ANALYZER WAS REPORTEDLY 10 PG/ML. THE REPEAT RESULT WAS RUN ON THE SECOND E411 IMMUNOASSAY ANALYZER AND THE RESULT WAS REPORTEDLY 135 PG/ML. THE INITIAL RESULT OF 10 PG/ML WAS REPORTED TO THE SURGEON. THE SURGEON THEN SENT A NEW SAMPLE TO THE LABORATORY TO BE TESTED TO VERIFY THE BASELINE (DUE TO THE REPORTEDLY LOW INITIAL RESULT FROM SAMPLE 1). SAMPLE 2: THE INITIAL RESULT OF THE SECOND SAMPLE RUN ON THE FIRST COBAS E411 IMMUNOASSAY ANALYZER WAS REPORTEDLY 76 PG/ML. THE REPEAT RESULT WAS RUN ON THE SECOND E411 IMMUNOASSAY ANALYZER AND THE RESULT WAS REPORTEDLY 77 PG/ML. THE REPEAT RESULT OF 77 PG/ML WAS ALLEGEDLY DEEMED TO BE CORRECT, REPORTED TO THE SURGEON, AND ESTABLISHED AS THE PTH BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695769 COBAS E 411 ANALYZER (DISK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 706358 04015630937103
    724453 COBAS E 411 ANALYZER (DISK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 706358 04015630937103

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Unknown