BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7448975 · Received April 20, 2018

    Report

    Report Number
    8031673-2018-00361
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    March 26, 2018
    Report Date
    April 20, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION BY MANUFACTURER: A (B)(4) COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2016 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. A (B)(64 COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR CALIBRATOR LOT NUMBER (B)(4) FROM (B)(6) 2016 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE INTACT PARATHYROID HORMONE ST AIA-PACK INTACT PTH ASSAY SPECIFICATIONS UNDER CALIBRATION, PAGE 5, STATES THE FOLLOWING: CALIBRATION, CALIBRATORS (2)-(6) FOR ST AIA-PACK INTACT PTH ARE LYOPHILIZED. ALL LEVELS SHOULD BE RECONSTITUTED WITH 1ML OF CAP CLASS I OR NCCLS (CLSI) TYPE I REAGENT GRADE WATER. TOSOH RECOMMENDS THAT ALL CALIBRATORS BE RUN IN TRIPLICATE. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO THE CALIBRATORS NOT BEING RECONSTITUTED WITH CAP CLASS I OR NCCLS (CLSI) TYPE I REAGENT GRADE WATER. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED OUT OF RANGE LOW INTACT PARATHYROID HORMONE (IPTH) CALIBRATOR RATES WITH LOT NUMBER H535258 ON THE AIA-2000 INSTRUMENT. THE CUSTOMER REPORTED THE DAILY CHECK PASSED AND QUALITY CONTROLS (QC) WERE WITHIN ACCEPTABLE RANGE. THE CUSTOMER REPEATED DAILY CHECK AND QC, WHICH PASSED AGAIN. THE TECHNICAL SUPPORT SPECIALIST SENT A NEW BOX OF CALIBRATORS FOR THE CALIBRATORS FOR THE CUSTOMER TO REPEAT CALIBRATION ON THE AIA-2000 INSTRUMENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR IPTH. ON (B)(6) 2018, THE CUSTOMER CONFIRMED THAT CALIBRATION PASSED WITH ACCEPTABLE RANGE WITH NEW CALIBRATORS; QC WAS ALSO WITHIN ACCEPTABLE RANGE. THE CUSTOMER AGREED THAT THE PREVIOUS CALIBRATORS WERE PROBABLY NOT RECONSTITUTED WITH REAGENT GRADE WATER. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291460 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1