BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 2969372 · Received February 20, 2013

    Report

    Report Number
    1823260-2013-01045
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 20, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ESTRADIOL RESULTS FOR THREE PATIENTS ON THEIR E411 ANALYZER. THE FIRST PATIENT'S INITIAL ESTRADIOL RESULT WAS 3920 PG/ML. THE SAMPLE WAS AUTOMATICALLY DILUTED 1:5 AND THE RESULT WAS 6604 PG/ML. THE SAMPLE WAS MANUALLY DILUTED 1:2 AND THE RESULT WAS 4466 PG/ML. THE SAMPLE WAS MANUALLY DILUTED 1:5 AND THE RESULT WAS 6310 PG/ML. THE SECOND PATIENT'S INITIAL ESTRADIOL RESULT WAS 3732 PG/ML. THE SAMPLE WAS AUTOMATICALLY DILUTED 1:5 AND THE RESULT WAS 6542 PG/ML. THE SAMPLE WAS MANUALLY DILUTED 1:2 AND THE RESULT WAS 4430 PG/ML. THE SAMPLE WAS MANUALLY DILUTED 1:5 AND THE RESULT WAS 6135 PG/ML. THE THIRD PATIENT'S INITIAL ESTRADIOL RESULT WAS 3809 PG/ML. THE SAMPLE WAS DILUTED 1:2 AND THE RESULT WAS 4470 PG/ML. THE SAMPLE WAS DILUTED 1:5 AND THE RESULT WAS 6285 PG/ML. IT WAS UNKNOWN IF ANY RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENTS HAD BEEN REPORTED. THE ESTRADIOL REAGENT LOT NUMBER WAS 168711 AND THE EXPIRATION DATE WAS NOT PROVIDED. FOUR SAMPLES WERE TESTED DURING THE INVESTIGATION USING ESTRADIOL REAGENT LOT NUMBERS 168711 AND 170338. THE SAMPLES WERE TESTED UNDILUTED, DILUTED 1:2, 1:5, AND 1:10. IN THIS INVESTIGATION, THE UNDILUTED RESULTS WERE FOUND TO BE OUTSIDE THE MEASURING RANGE, DIFFERING FROM THE CUSTOMER. THE DILUTED RESULTS GENERALLY MATCHED THE UNDILUTED RESULTS. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73884 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1