BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 5173544 · Received October 24, 2015

    Report

    Report Number
    1823260-2015-04395
    Event Type
    Malfunction
    Date Received
    October 24, 2015
    Date of Event
    September 25, 2015
    Report Date
    November 18, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. FROM THE PROVIDED CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE WAS EXCLUDED. A PREANLYTICAL ISSUE WAS SUSPECTED AS UPON RECENTRIFUGATION OF THE SAMPLE, THE RESULTS GENERATED WERE IN THE SAME RANGE AS THE NEW BLOOD DRAW AND ALARMS WERE NOTED INDICATING A BUBBLE IN THE SAMPLE.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE THYROID RESULTS FOR ONE PATIENT SAMPLE. OF THE DATA PROVIDED, ONLY THE RESULTS FOR FREE THYROXINE (FT4) WERE DISCREPANT. THE INITIAL RESULT WAS 3.25 PMOL/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN DID NOT BELIEVE THE RESULT AND ORDERED A NEW BLOOD DRAW FROM THE PATIENT. THE RESULT FROM THE NEW BLOOD DRAW WAS 11.5 PMOL/L. THE PRIMARY TUBE OF THE ORIGINAL SAMPLE WAS RECENTRIFUGED AND A NEW ALIQUOT WAS TESTED ON (B)(6) 2015 WITH A RESULT OF 12.4 PMOL/L. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 183473. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704751 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1