BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSOH AIA-2000

    MDR report key: 4095055 · Received August 11, 2014

    Report

    Report Number
    3005529799-2014-00012
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    July 23, 2014
    Report Date
    August 11, 2014
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    KHO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, TOSOH BIOSCIENCE, INC. RECEIVED INFORMATION THAT A CUSTOMER HAD NOTED ERRATIC TROPONIN RESULTS ON THE TOSOH AIA-2000 ANALYZER. ONE TROPONIN RESULT HAD BEEN QUESTIONED BY THE PHYSICIAN AND WAS REPEATED. THE REPEAT RESULTS DID NOT CORRELATE WITH THE PREVIOUSLY REPORTED RESULT. THE INVESTIGATION INDICATED TWO OTHER SPECIMENS THAT HAD ALSO HAD ERRATIC RESULTS, BUT INCORRECT RESULTS WERE NOT REPORTED. ALL QC RESULTS WERE WITHIN ACCEPTABLE RANGE. ROOT CAUSE: UNABLE TO DEFINITIVELY DETERMINE, BUT SPECIMEN DRAW TUBES MAY BE A CONTRIBUTING FACTOR. THE LAB HAD CHANGED SPECIMEN COLLECTION TUBES FROM NON-GEL TUBES TO LITHIUM HEPARIN GEL TUBES. THIS IS FURTHER EVIDENCED BY THE FACT THAT THE LAB IS POURING OFF THEIR SPECIMENS AND SINCE DOING SO HAVE NOT SEEN ANY OUTLIERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476042 TOSOH AIA-2000 TOSOH AIA-2000 KHO TOSOH HI-TEC, INC. AIA-2000LA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other