BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 4680429 · Received April 10, 2015

    Report

    Report Number
    1823260-2015-02906
    Event Type
    Malfunction
    Date Received
    April 10, 2015
    Date of Event
    March 31, 2015
    Report Date
    April 19, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS BEEN CONFIRMED TO BE EXACTLY (B)(6).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). A PATIENT AGE OF (B)(6) YEARS WAS ALSO PROVIDED. A CLARIFICATION HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. CALIBRATION AND QUALITY CONTROLS WERE WITHIN SPECIFICATION. THERE WAS NO REAGENT ISSUE EVIDENT. A TEMPORARY INSTRUMENT ISSUE COULD NOT BE EXCLUDED. THE ISSUE MAY BE RELATED TO PRE-ANALYTIC SAMPLE HANDLING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS- SUBUNIT (HCGB). THE SAMPLE INITIALLY RESULTED AS 49.08 IU/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED TWICE AND RESULTED AS < 7 IU/L EACH TIME. ONE OF THE REPEAT RESULTS WAS 1.25 IU/L, TESTED ON 04/01/2015. THE EXPECTED RESULT FOR THE PATIENT WAS "NEGATIVE". THE PATIENT WAS NOT ADVERSELY AFFECTED. THE HCGB REAGENT LOT NUMBER WAS 183183. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238724 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 026 YR