BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 4221440 · Received November 3, 2014

    Report

    Report Number
    1823260-2014-08490
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 20, 2014
    Report Date
    November 3, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ANTIBODIES TO TSH RECEPTOR (ANTI- TSHR) RESULTS FOR ONE PATIENT SAMPLE. THE RESULTS WERE 6.88 IU/L, 3.65 IU/L AND 1.44 IU/L. INFORMATION CONCERNING WHICH RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED, BUT WAS NOT PROVIDED. NO ADVERSE EVENT WAS REPORTED. THE ANTI-TSHR REAGENT LOT NUMBER WAS 176161 WITH AN EXPIRATION DATE OF 07/30/2015. THE REPORTED PATIENT SAMPLE WAS MEASURED WITH AN "INSEPACK TUBE" BECAUSE THE SAMPLE WAS "GETTING HARD BECAUSE OF FIBRIN". IF THERE IS FIBRIN PRESENT IN A SAMPLE, SERUM FROM THE SAMPLE WOULD BE TRANSFERRED TO AN "INSEPACK TUBE" FROM THE PRIMARY BLOOD COLLECTION TUBE, REMIXED AND REMEASURED. IT COULD NOT BE CONFIRMED WHICH RESULT WAS GENERATED FROM THE PRIMARY BLOOD COLLECTION TUBE OR THE INSEPACK TUBE. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. THE MOST LIKELY CAUSE WAS A PREANALYTICAL ISSUE AS FIBRIN WAS OBSERVED IN THE SAMPLE AND THE "INSEPACK TUBE" WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701353 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1