BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 6853892 · Received September 8, 2017

    Report

    Report Number
    8031673-2017-00025
    Event Type
    Malfunction
    Date Received
    September 8, 2017
    Date of Event
    August 10, 2017
    Report Date
    October 25, 2018
    Manufacturer
    TOSOH HI-TEC
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. DEVICE EVALUATION BY MANUFACTURER: THE FSE (FIELD SERVICE ENGINEER) PERFORMED THE SERVICE ON 15AUG2017 AS STATED IN THE SERVICE REPORT.

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: ON 14-AUG-2017 A FIELD SERVICE ENGINEER (FSE) INSPECTED THE AIA-2000 ANALYZER FOR LEAKS OR ABNORMALITIES AND NONE WERE FOUND. THE FSE RAN DAILY CHECK AND PRECISION OF IPTH. PRECISION OF IPTH PERFORMED ON A PATIENT SAMPLE OBTAINED A CV% WHICH WAS WITHIN NORMAL RANGE. THE FSE COULD NOT DUPLICATE THE REPORTED DISCREPANT IPTH PATIENT RESULT. THE AIA-2000 WAS PERFORMING WITHIN SPECIFICATIONS. A 13-MONTH COMPLAINT HISTORY REVIEW FOR (B)(4) FOUND TWO SIMILAR COMPLAINTS DURING THIS TIME PERIOD, INCLUDING THIS EVENT. THE ROOT CAUSE OF THE REPORTED DISCREPANT IPTH PATIENT RESULT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED A PARATHYROID HORMONE (IPTH) PATIENT RESULT OF 1.1 PG/ML AND UPON REPEAT IT WAS 68 PG/ML (NORMAL RANGE 1.0 PG/ML-2000 PG/ML). THE CUSTOMER REPORTED THAT BIO-RAD QUALITY CONTROLS (QC) WERE WITHIN ACCEPTABLE RANGE. THE CUSTOMER REPORTED THAT THE SAMPLE WAS CLOTTED FOR 30 TO 60 MINUTES AND SPUN FOR 10 MINUTES. THE CUSTOMER RUNS SAMPLES AND QC IN INSERT CUPS INSIDE THE ORIGINAL BARCODED TUBES. SOME SAMPLES ARE FROZEN, BUT THE CUSTOMER DID NOT KNOW IF THE SAMPLE IN QUESTION WAS. THE CUSTOMER STATED THAT THE IPTH PATIENT RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THERE WAS NO CHANGE IN PATIENT TREATMENT AS A RESULT OF THE DISCREPANT IPTH RESULT. THE CUSTOMER AGREED TO PERFORM PRECISION ON IPTH. ON 14-AUG-2017 A FIELD SERVICE ENGINEER PERFORMED PRECISION ON IPTH AND THE COEFFICIENT OF VARIATION (CV%) WAS 3.13%, WHICH WAS WITHIN NORMAL RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631336 AIA-2000 AIA-2000 KHO TOSOH HI-TEC AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1