BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-TSHR

    MDR report key: 19871701 · Received July 31, 2024

    Report

    Report Number
    1823260-2024-02215
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    June 28, 2024
    Report Date
    August 6, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZO
    PMA / PMN Number
    K193313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE E601 ANALYZER IS (B)(6). BASED ON THE PROVIDED CALIBRATION DATA, THE LAST CALIBRATION TOOK PLACE ON (B)(6) 2023. QUALITY CONTROLS WERE ACCEPTABLE. THE CUSTOMER CONFIRMED THEY USE 13 MM. DIAMETER TUBES. IT WAS OBSERVED THAT SOME RACKS DID NOT HAVE ADAPTERS REQUIRED FOR 13 MM. DIAMETER TUBES. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED THAT THE SAMPLE VOLUME WAS RELATIVELY SMALL. NO INSTRUMENT ISSUES WERE OBSERVED. BASED ON THE INFORMATION, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE. THE ISSUE IS CONSISTENT WITH A SMALL SAMPLE VOLUME IN COMBINATION WITH THE USE OF 13 MM. SAMPLE TUBES WITHOUT RACK ADAPTERS REQUIRED FOR 13 MM. DIAMETER TUBES.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS ANTI-TSHR ON A COBAS 6000 E601 MODULE. THE SAMPLE INITIALLY RESULTED IN AN ANTI-TSHR VALUE OF < 0.800 IU/L WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN A VALUE OF 6.37 IU/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740513 ELECSYS ANTI-TSHR THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM JZO ROCHE DIAGNOSTICS 709087

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female