BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 7302338 · Received February 28, 2018

    Report

    Report Number
    1823260-2018-00609
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Date of Event
    February 9, 2018
    Report Date
    March 27, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)# (B)(4). THE EVENT OCCURRED IN: (B)(6).

    Additional Manufacturer Narrative · 1

    A FIELD ENGINEERING SPECIALIST PERFORMED PRECISION TESTING AND DECONTAMINATED THE SYSTEM. THE INVESTIGATION IS CURRENTLY ONGOING.

    Additional Manufacturer Narrative · 1

    THE FIELD ENGINEERING SPECIALIST PERFORMED MULTIPLE MECHANICAL CHECKS BUT WAS NOT ABLE TO FIND A ROOT CAUSE. FOLLOWING THE DECONTAMINATION PERFORMED BY THE FIELD ENGINEERING SPECIALIST, THE CUSTOMER HAS NOT REPORTED ANY FURTHER ISSUES. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS ESTRADIOL III ASSAY (E2 III) ON A COBAS E 411 IMMUNOASSAY ANALYZER. PATIENT 1 INITIAL E2 III RESULT WAS 3991 PMOL/L. THE SAMPLE WAS TESTED ON ANOTHER COBAS E411 WITH AN E2 III RESULT OF 9363 PMOL/L. THE SAMPLE WAS RETESTED ON THE ORIGINAL COBAS E411 WITH AN E2 III RESULT OF 9215 PMOL/L. ON (B)(6) 2018 PATIENT 2 INITIAL E2 III RESULT WAS >11010 PMOL/L, WITH A DATA FLAG. THE SAMPLE WAS RETESTED WITH A 1:5 DILUTION WITH AN E2 III RESULT OF 413.2 PMOL/L. THE SAMPLE WAS TESTED ON ANOTHER COBAS E411 WITH AN E2 III RESULT OF 219.4 PMOL/L. THE SAMPLE WAS RETESTED ON THE ORIGINAL COBAS E411 WITH AN E2 III RESULT OF 207.6 PMOL/L. THE ERRONEOUS RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE E2 III REAGENT LOT WAS 252578 WITH AN EXPIRATION DATE THAT WAS NOT PROVIDED. THE FIELD ENGINEERING SPECIALIST WAS UNABLE TO FIND A ROOT CAUSE. AS A PREVENTATIVE ACTION HE CLEANED THE FLUIDICS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148469 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 RACK NA

    Patients

    Seq Age Sex Outcome Treatment
    1