BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOSOH AIA-360

    MDR report key: 5896196 · Received August 23, 2016

    Report

    Report Number
    3005529799-2016-00012
    Event Type
    Other
    Date Received
    August 23, 2016
    Date of Event
    July 29, 2016
    Report Date
    August 9, 2016
    Manufacturer
    TOSOH HI-TEC
    Product Code
    KHO
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016 TOSOH BIOSCIENCE, INC. WAS NOTIFIED THAT AN INCORRECT TROPONIN RESULT TESTED ON A TOSOH AIA-360 HAD BEEN REPORTED. INITIAL PATIENT RESULT WAS 1.45 NG/ML. PATIENT WAS TRANSFERRED TO THE MEDICAL CENTER WHERE THE TROPONIN RESULT WAS NORMAL AT <0.06 NG/ML THE INITIAL SPECIMEN WAS RETESTED AND RETEST RESULT WAS ALSO NORMAL AT < 0.06 NG/ML. ROOT CAUSE: UNKNOWN, BUT SUSPECTED SPECIMEN INTEGRITY SINCE SERUM WAS THE SPECIMEN TYPE AND CLOT TIME AND CENTRIFUGATION TIME WAS UNKNOWN. RECOMMENDED USE OF HEPARINIZED PLASMA FOR TROPONIN TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550781 TOSOH AIA-360 360 KHO TOSOH HI-TEC AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1 Other