BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 2969366 · Received February 20, 2013

    Report

    Report Number
    1823260-2013-01048
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 20, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 A QUESTIONABLE ESTRADIOL RESULT FOR ONE PATIENT ON THEIR E602 ANALYZER. THE PATIENT'S SAMPLE WAS PROCESSED THROUGH THE LABORATORY'S MODULAR PRE ANALYTICS DEVICE AND ALIQUOTED INTO A SAMPLE CUP. THE PATIENT'S INITIAL ESTRADIOL RESULT WAS 222.7 NG/L AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S TWO PRIMARY TUBES WERE TESTED AND THE RESULTS WERE <5 NG/L ACCOMPANIED BY DATA FLAGS. THE REPEAT RESULTS WERE CONSIDERED CORRECT. THE DOCTOR HAD PLANNED TO HOSPITALIZE AND SCAN THE PATIENT, BUT THIS WAS CANCELLED AFTER THE REPEAT RESULTS WERE OBTAINED. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE ESTRADIOL REAGENT LOT NUMBER WAS 170338 AND THE EXPIRATION DATE WAS NOT PROVIDED. THE CALIBRATION AND QUALITY CONTROL DATA WAS WITHIN SPECIFICATIONS, AND THERE WAS NO REAGENT ISSUE EVIDENT. IT WAS NOTED THE CUSTOMER WAS NOT FOLLOWING THE TUBE MANUFACTURER'S RECOMMENDED CENTRIFUGATION SPECIFICATIONS. THERE WAS NO INSTRUMENT ISSUE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73883 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 011 YR