BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH ST AIA 25-OH VITAMIN D PRETREATMENT SET

    MDR report key: 7445850 · Received April 19, 2018

    Report

    Report Number
    3005529799-2015-00008
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    July 7, 2015
    Report Date
    February 5, 2021
    Manufacturer
    TOSOH CORPORATION
    Product Code
    MRG
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS REPORT IS BEING REFILED PER FDA REQUEST TO CLARIFY AN EARLIER ERROR WITH UF/IMPORTER REPORT #: (B)(4). THIS REPORT IS AN "INITIAL" TO UF/IMPORTER REPORT #: (B)(4). APART FROM SELECTING "INITIAL" ALL OTHER INFORMATION IS THE SAME AS STATED IN (B)(4) FOLLOW UP1. THE INITIAL MDR WAS FILED AS UF/IMPORTER REPORT #: (B)(4) IN ERROR. THE CORRECT UF/IMPORTER REPORT # IS (B)(4). CONTACT OFFICE: (B)(4). MANUFACTURING SITE: (B)(4). 510K: K123131. ADVERSE EVENT: FOLLOW-UP # 1. TYPE OF EVENT: MALFUNCTION. FOLLOW UP: CORRECTION. ADVERSE EVENT CODES: (B)(4). USAGE OF DEVICE: REUSE. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA(B)(4). SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    ON 09-JUL-2015, THE CUSTOMER CALLED TOSOH TECHNICAL SUPPORT TO REPORT THAT THEY DETERMINED INCORRECT VITAMIN D PATIENT RESULTS WERE SENT TO THE DOCTOR. THE CUSTOMER FURTHER REPORTED THAT THE QUALITY CONTROLS (QC) RUN WERE ALL WITHIN THE ACCEPTABLE TARGET RANGE. QC LEVEL 1 RESULT: 46.1 (ACCEPTABLE RANGE: 42.2 - 52.2) AND QC LEVEL 2 RESULT: 79.7 (ACCEPTABLE RANGE (65.7 - 89.7). TOSOH TECHNICAL SUPPORT WILL SEND NEW PRE-TREATMENT REAGENT FOR THE VITAMIN D TESTS. THE CUSTOMER WILL RUN VITAMIN D PATIENT TESTS FOR THE NEXT 2 WEEKS ONLY USING A BOTTLE OF PRETREATMENT FOR ONE (1) DAY INSTEAD OF TWO (2) DAYS. THE CUSTOMER INDICATED THAT THE ISSUE OCCURS ON THE SECOND DAY OF PRETREATMENT USE. THE CUSTOMER REPORTED THAT THEY WERE REFRIGERATING VITAMIN D PRETREATMENT AFTER 12 HOURS INSTEAD OF 8 HOURS AND THEN REUSING THE BOTTLE OF PRETREATMENT A SECOND DAY FOR ANOTHER 12 HOURS. THE CUSTOMER REPORTED THAT THE ONE (1) PATIENT INCORRECT VITAMIN D RESULT WHICH WAS SENT TO THE PHYSICIAN RESULTED IN NO TREATMENT AS THE DOCTOR WAS NOTIFIED FIRST THING NEXT MORNING OF THE ERROR. THE TEST WAS RERUN WITH FRESH PRETREATMENT REAGENT AND THE RESULT WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288594 TOSOH ST AIA 25-OH VITAMIN D PRETREATMENT SET VITAMIN D PRETREATMENT, PRODUCT CODE: MRG MRG TOSOH CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown AIA-2000ST, SERIAL NUMBER (B)(4) | QUALITY CONTROLS BIO-RAD LOT 57430