BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 3393393 · Received October 8, 2013

    Report

    Report Number
    1823260-2013-06155
    Event Type
    Malfunction
    Date Received
    October 8, 2013
    Date of Event
    September 17, 2013
    Report Date
    October 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL DATA WERE REQUESTED BUT NOT PROVIDED. THE CALIBRATION AND QUALITY CONTROL WERE WITHIN RANGE. NO REAGENT ISSUE WAS EVIDENT.

    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 E602 ANALYZER. THE PATIENT'S INITIAL HCGB RESULT WAS 0.100 MUI/ML ACCOMPANIED BY A DATA FLAG. THE INITIAL RESULT WAS RELEASED TO THE PATIENT WHO DID NOT AGREE WITH THE RESULT BECAUSE IN (B)(6) THE PATIENT HAD AN HCGB RESULT OF 815.6 MUI/ML. AFTER THE PATIENT COMPLAINED, THE CUSTOMER REPEATED THE SAMPLE ON (B)(6) 2013 ON THE E602 AND THE RESULT WAS 10000 MUI/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:100 AND THE RESULT WAS 102413 MUI/ML. THE CUSTOMER REPEATED THE SAMPLE ON AN ANALYTIC E MODULE AND THE RESULT WAS 10000 MUI/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED AND THE RESULT WAS 96305 MUI/ML. THERE WERE NO ADVERSE EVENTS. THE HCGB REAGENT LOT NUMBER WAS 171601. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508103 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 035 YR