BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSOH ST AIA 25-OH VITAMIN D PRETREATMENT SET

    MDR report key: 4941857 · Received July 23, 2015

    Report

    Report Number
    3005529799-2014-00008
    Event Type
    Injury
    Date Received
    July 23, 2015
    Report Date
    July 22, 2015
    Manufacturer
    TOSOH AIA
    Product Code
    MRG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015 TOSOH BIOSCIENCE, INC. WAS NOTIFIED THAT ON (B)(6) 2015 VITAMIN D RESULTS WERE REPORTED THAT WERE DETERMINED TO BE INCORRECT. THE QCS WERE ALL WITHIN THE ACCEPTABLE TARGET RANGE. IT WAS NOTED THAT THE VITAMIN D ISSUE ALWAYS OCCURRED ON THE SECOND DAY OF USE OF THE PRE-TREATMENT (PT) SOLUTION. THE FRESH PT WAS BEING USED FOR 12 HOURS ON BOARD THE ANALYZER, HOWEVER THE STABILITY CLAIM IS ONLY FOR 6 HOURS, SO THE REAGENT STABILITY WAS BEING EXCEEDED. ROOT CAUSE: OPERATOR ERROR. REAGENT STABILITY EXCEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478056 TOSOH ST AIA 25-OH VITAMIN D PRETREATMENT SET VITAMIN D PRETREATMENT MRG TOSOH AIA NA F20B716

    Patients

    Seq Age Sex Outcome Treatment
    1 Other