BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 5010671 · Received August 18, 2015

    Report

    Report Number
    1823260-2015-03986
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    July 20, 2015
    Report Date
    December 15, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. A REAGENT OR CALIBRATOR ISSUE COULD BE EXCLUDED AS THE CALIBRATION SIGNALS WERE PLAUSIBLE AND QUALITY CONTROL RESULTS WERE WITHIN RANGE.

    Additional Manufacturer Narrative · 1

    (B)(6). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE FREE THYROXINE (FT4) RESULTS FOR TWO PATIENTS AND QUESTIONABLE ANTIBODIES TO THYROID PEROXIDASE (ANTI-TPO) RESULTS FOR THREE PATIENT SAMPLES. OF THE DATA PROVIDED, ONLY THE FT4 RESULTS WERE A REPORTABLE MALFUNCTION. PATIENT 1 INITIAL RESULT WAS 2.1 NG/DL. THE REPEAT RESULT ON ANOTHER ANALYTICAL E MODULE WAS 1.3 NG/ML. PATIENT 2 WAS A FEMALE, (B)(6). THE INITIAL RESULT WAS 2.2 NG/DL. THE REPEAT RESULT ON ANOTHER ANALYTICAL E MODULE WAS 1.3 NG/ML. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. INFORMATION CONCERNING IF ANY PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED, BUT WAS NOT PROVIDED. NO ADVERSE EVENT WAS REPORTED. 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
    544049 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR