BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSOH AIA-2000

    MDR report key: 3233253 · Received July 12, 2013

    Report

    Report Number
    3005529799-2013-00009
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    MRG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, TOSOH BIOSCIENCE DETERMINED THAT CORRELATION RESULTS BETWEEN THE TOSOH AND AN ALTERNATE METHOD SHOWED AN UNEXPLAINED NEGATIVE BIAS. DURING THE INVESTIGATION, IT BECAME APPARENT THAT THE CUSTOMER HAD INCORRECT TEST PARAMETERS SET FOR VITAMIN D ON THE TOSOH AIA-2000. INCORRECT PATIENT RESULTS HAD BEEN REPORTED PRIOR TO THAT DATE. THE TEST PARAMETERS WERE CORRECTED AND OUT OF RANGE LOW SPECIMENS WERE REPEATED AND RESULTS CORRECTED ACCORDING TO THE CUSTOMER. THERE IS NO EVIDENCE THAT PATIENTS WERE TREATED BECAUSE OF THE RESULTS. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321664 TOSOH AIA-2000 AIA-2000 MRG TOSOH HI-TEC, INC. AIA-2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other