BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 3031953 · Received April 3, 2013

    Report

    Report Number
    1823260-2013-02000
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE CALIBRATION AND QUALITY CONTROL RESULTS WERE WITHIN SPECIFICATION. THERE WAS NO REAGENT ISSUE EVIDENT. THE INSTRUMENT MESSAGE HISTORY SHOWED AN ANALYZER ALARM AROUND THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCGB) RESULT FOR ONE PATIENT ON THEIR E411 ANALYZER. THE PATIENT'S INITIAL HCGB RESULT WAS 86 IU/L AND IT WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2013, THE DOCTOR REQUESTED ANOTHER SAMPLE BE COLLECTED AND THE HCGB RESULT WAS 86000 IU/L, SHOWING THE PATIENT WAS STILL PREGNANT. THE DOCTOR THEN REQUESTED THE INITIAL SAMPLE BE REPEATED. ON (B)(6) 2013, THE PATIENT'S INITIAL SAMPLE WAS DILUTED AND THE REPEAT RESULT WAS 76516 IU/L. WHEN THE SAMPLE WAS REPEATED ON (B)(6) 2013, THE CUSTOMER NOTICED THERE WAS SOME FIBRIN DEBRIS ON THE GEL OF THE SAMPLE AND REMOVED IT BEFORE RETESTING. THE PATIENT'S PREGNANCY WAS NOT HARMED BY THIS EVENT, AND THERE WERE NO ADVERSE EVENTS. THE HCGB REAGENT LOT NUMBER WAS 169563 AND THE EXPIRATION DATE WAS 01/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136371 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 026 YR