BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 8727818 · Received June 24, 2019

    Report

    Report Number
    1823260-2019-02292
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    June 3, 2019
    Report Date
    June 24, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPLACED THE REAGENT, DILUENT, PROCELL, AND CLEANCELL SOLUTIONS. THE FIELD SERVICE REPRESENTATIVE FOUND THE PINCH VALVE WAS NOT WORKING CORRECTLY, THE SIPPER PROBE WAS OUT OF ALIGNMENT, THERE WAS A HOLE IN THE TUBING, AND THE MIXER MOTOR SHAFT WAS BENT. HE REPLACED THE TUBING AND ADJUSTED THE SIPPER PROBE ALIGNMENT. CUSTOMER RAN CALIBRATION AND QC WITH ALL RESULTS WITHIN SPECIFIED RANGES. BASED ON THE QC DATA, A GENERAL PERFORMANCE ISSUE OF THE REAGENT OR INSTRUMENT WAS RULED OUT. THE INVESTIGATION DETERMINED THE ISSUE WAS RESOLVED BY THE SERVICE ACTIONS.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE TROPONIN T GEN5 STAT RESULTS FOR THREE PATIENTS FROM THE COBAS E 411 DISK ANALYZER. PATIENT 1 INITIAL RESULT WAS 16 NG/L AND THE REPEAT RESULT WAS 10 NG/L. PATIENT 2 INITIAL RESULT WAS 15 NG/L AND THE REPEAT RESULT WAS 8 NG/L. PATIENT 3 INITIAL RESULT WAS 20 NG/L AND THE REPEAT RESULT WAS 11 NG/L. THEY INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY TO THE PROVIDER. CORRECTED REPORTS WERE ISSUED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 38154200 WITH A N EXPIRATION DATE OF 31-MAY-2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520711 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 DISK NA

    Patients

    Seq Age Sex Outcome Treatment
    1