BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSOH AIA ST VITAMIN D PRETREATMENT

    MDR report key: 4172255 · Received October 3, 2014

    Report

    Report Number
    3005529799-2014-00015
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 18, 2014
    Report Date
    October 3, 2014
    Manufacturer
    TOSOH AIA, INC.,
    Product Code
    MRG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    (B)(6), 2014 CUSTOMER TESTED APPROXIMATELY 100 SPECIMENS FOR VARIOUS IMMUNOS ASSAYS ON THE TOSOH AIA-2000. IT WAS NOTED THAT MANY OF THE VITAMIN D SPECIMENS HAD RESULTS <4.0 NG/ML. THREE SPECIMENS REPEATED AND RESULTS WERE NORMAL. ALL QC WITHIN RANGE. PRETREATMENT OPENED (B)(6), 2014. RUN WAS NOT VERIFIED AND NO RESULTS WERE SENT OUT. (B)(6), 2014 VITAMIN D WAS RECALIBRATED AND THE SAME PRETREATMENT WAS USED. SIX SPECIMENS HAD VITAMIN D RESULTS THAT WERE <4.0 NG/ML AND THE RESULTS WERE SENT. (B)(6), 2014 TOSOH BIOSCIENCE, INC. NOTIFIED OF ERRONEOUS VITAMIN D RESULTS THAT HAD BEEN REPORTED BY THE CUSTOMER. (B)(6), 2014 SIX SPECIMENS REPORTED AS <4.0 NG/ML ON (B)(6), 2014 WERE REPEATED, RESULTS WERE NORMAL, AND CORRECTED REPORTS WERE ISSUED. ROOT CAUSE: PRETREATMENT USED BEYOND STATED ROOM TEMPERATURE STABILITY TIME FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617735 TOSOH AIA ST VITAMIN D PRETREATMENT AIA VITAMIN D PRETREATMENT MRG TOSOH AIA, INC., N/A E50B711

    Patients

    Seq Age Sex Outcome Treatment
    1 Other