BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 11485178 · Received March 15, 2021

    Report

    Report Number
    1823260-2021-00789
    Event Type
    Malfunction
    Date Received
    March 15, 2021
    Date of Event
    February 22, 2021
    Report Date
    April 27, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THERE WAS FOAM PRESENT IN THE REAGENT CASSETTE. THE FIELD SERVICE ENGINEER PERFORMED THE FOLLOWING: -CALIBRATION ON PADDLE MIXER POSITIONS. -CLEANING AND CALIBRATION OF THE SAMPLING NEEDLE. -CALIBRATION OF THE SIPPER NEEDLE. -WATER QUALITY CHECK WITH AN AUTOMATIC TEST. THE CUSTOMER'S QC PASSED AFTER THE SERVICE VISIT AND NO OTHER COMPLAINTS WERE REPORTED. IT WAS CONFIRMED THAT THE INSTRUMENT IS WORKING ACCEPTABLY.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI) # (B)(4). THE COUNTRY OF ORIGIN IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE ELECSYS CMV IGG ASSAY RESULTS FOR 2 SAMPLES ON A COBAS E 411 IMMUNOASSAY ANALYZER. SAMPLE 1: THE INITIAL RESULT WAS <0.150 U/ML AND THE REPEAT RESULTS WERE 176.4 U/ML, <0.150 U/ML, AND 175.7 U/ML. SAMPLE 2: THE INITIAL RESULT WAS <0.150 U/ML AND THE REPEAT RESULT WAS >500 U/ML. THE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE REAGENT LOT NUMBER WAS 4813401 AND THE EXPIRATION DATE WAS 30-SEP-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387578 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 RACK NA

    Patients

    Seq Age Sex Outcome Treatment
    1