BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E-ELECSYS ANTI-TSHR

    MDR report key: 4918838 · Received July 16, 2015

    Report

    Report Number
    1823260-2015-03812
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    May 20, 2015
    Report Date
    July 28, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZO
    PMA / PMN Number
    K080092
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED AN IMPLAUSIBLE HIGH ANTI-TSHR (ANTIBODIES TO TSH RECEPTOR) RESULT FOR ONE PATIENT SAMPLE FROM A COBAS E602 ANALYZER. THE RESULTS PROVIDED WERE: ANTI-TSHR: 5.2 IU/L T4: 129.4 NMOL/L T3: 2.8 NMOL/L FT3: 4.7 PMOL/L FT4: 12 PMOL/L TSH: 0.94 MIU/L INFORMATION CONCERNING IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY OR IF THE PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED, BUT WAS NOT PROVIDED. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION AND THE FT4 AND FT3 RESULTS WERE WITHIN THE REFERENCE RANGES. NO INTERFERENCE TO STREPTAVIDIN COULD BE FOUND IN THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462643 COBAS E-ELECSYS ANTI-TSHR THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM JZO ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1