BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (RACK SYSTEM)

    MDR report key: 20895383 · Received December 10, 2024

    Report

    Report Number
    1823260-2024-03605
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 29, 2024
    Report Date
    December 10, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924721
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HCG+BETA REAGENT LOT NUMBER WAS 77493001. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE CUSTOMER STATED THAT CONTROLS WERE OUTSIDE OF RANGE AT THE TIME OF THE EVENT. THE FIELD SERVICE ENGINEER FOUND A CONTAMINATED SAMPLE PROBE. THE PROBE WAS CLEANED. PRECISION STUDIES AND PERFORMANCE TESTING WERE CARRIED OUT. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FIVE PATIENT SAMPLES TESTED WITH ELECSYS HCG+BETA ON A COBAS E 411 ANALYZER. THE CUSTOMER NOTICED A LARGE DIFFERENCE IN PATIENT VALUES, SO THEY DECIDED TO REPEAT THE PATIENT SAMPLES. THE SAMPLES WERE REPEATED. THE FIRST SAMPLE INITIALLY RESULTED IN AN HCG+BETA VALUE OF 12.25 UIU/L AND IT REPEATED AS 0.463 UIU/L. THE CUSTOMER DEEMED A VALUE OF < 1 UIU/L TO BE CORRECT. THE SECOND SAMPLE INITIALLY RESULTED IN AN HCG+BETA VALUE OF 10.13 UIU/L. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 1.67 UIU/L AND 0.498 UIU/L. THE CUSTOMER DEEMED A VALUE OF < 1 UIU/L TO BE CORRECT. THE THIRD SAMPLE INITIALLY RESULTED IN AN HCG+BETA VALUE OF 31.8 UIU/L. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 1.09 UIU/L AND 0.232 UIU/L. THE CUSTOMER DEEMED A VALUE OF < 1 UIU/L TO BE CORRECT. THE FOURTH SAMPLE INITIALLY RESULTED IN AN HCG+BETA VALUE OF 38.72 UIU/L. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 4.75 UIU/L AND 4.64 UIU/L. THE CUSTOMER DEEMED A VALUE OF 5 UIU/L TO BE CORRECT. THE FIFTH SAMPLE INITIALLY RESULTED IN AN HCG+BETA VALUE OF 33.27 UIU/L AND IT REPEATED AS < 1 UIU/L. THE CUSTOMER DEEMED A VALUE OF < 1 UIU/L TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677856 COBAS E 411 ANALYZER (RACK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown