BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOSOH BIOSCIENCE AIA-2000LA

    MDR report key: 4651354 · Received March 30, 2015

    Report

    Report Number
    3005529799-2015-00004
    Event Type
    Other
    Date Received
    March 30, 2015
    Date of Event
    March 14, 2015
    Report Date
    March 30, 2015
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    KHO
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2015 AT 0200 TOSOH ST AIA TSH QCS WERE RUN AND ALL QC VALUES WERE WITHIN TARGET RANGE. AFTER THE QCS WERE RUN THE ANALYZER WENT INTO ABORT MODE AND REPORTED TWO ERRORS. THE CUSTOMER RECOVERED THE ANALYZER FROM THE ABORT MODE AND WAS ABLE TO RESTART TESTING. AT 1400, 12 HOURS AFTER THE ACCEPTABLE QC RESULTS, A ST TSH PT RESULT OF 20.41 UIU/ML WAS RECEIVED AND REPORTED TO A PHYSICIAN. ON (B)(6) 2015 THE PHYSICIAN QUESTIONED THE ST TSH RESULT OF 20.41 UIU/ML. THE PT WAS REDRAWN AND THE ST TSH RESULT FOR THE REDRAW SPECIMEN = 0.04 UIU/ML. ON (B)(6) 2015 ST TSH (REDRAW) SPECIMEN 0.04 UIU/ML ON (B)(6) 2015 ST TSH ((B)(6) 2015 REDRAW SPECIMEN) REPEAT = 0.05 UIU/ML. LAB INDICATED THAT THE PT HAD NOT BEEN TREATED BASED ON THE INCORRECT ST TSH RESULT. TOSOH FIELD SERVICE CHECKED THE ANALYZER AND WAS UNABLE TO DUPLICATE THE ISSUE. ROOT CAUSE: UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208903 TOSOH BIOSCIENCE AIA-2000LA AIA-2000 KHO TOSOH HI-TEC, INC. AIA-2000LA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other