BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7442122 · Received April 18, 2018

    Report

    Report Number
    8031673-2018-00310
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    March 19, 2018
    Report Date
    April 18, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. THE AIA-360, SERIAL NUMBER (B)(4), WAS INSTALLED AT THE ACCOUNT ON (B)(6) 2017. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FROM 10-AUG-2017 THROUGH AWARE DATE 19-MAR-2018. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE INTACT PARATHYROID HORMONE ST AIA-PACK INTACT PTH ASSAY SPECIFICATIONS UNDER LIMITATION OF THE PROCEDURE, PAGE 8, FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD BE USED IN CONJUNCTION WITH OTHER DATA (E.G., SYMPTOMS, RESULTS OF OTHER TESTS, CLINICAL IMPRESSIONS, THERAPY, ETC.). CERTAIN MEDICATIONS MAY INTERFERE WITH ASSAY PERFORMANCE. ALL RESULTS SHOULD BE INTERPRETED WITH RESPECT TO THE CLINICAL PICTURE OF THE PATIENT. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CUSTOMER REPORTED THAT UPON REPEAT THE IPTH RESULT WAS WITHIN ACCEPTABLE RANGE.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED A LOW INTACT PARATHYROID HORMONE (IPTH) PATIENT RESULT OF 1.3 PG/ML, WHICH UPON REPEAT OBTAINED A RESULT OF 63.5 PG/ML (REFERENCE RANGE 8.2 - 83.5 PG/ML) ON THE AIA-360 INSTRUMENT. THE CUSTOMER STATED THAT QUALITY CONTROLS (QC) WERE WITHIN ACCEPTABLE RANGE. THE CUSTOMER STATED THAT THERE WERE NO ERRORS WHEN THE SUBJECT SAMPLE WAS RUN ON THE AIA-360 INSTRUMENT. THE CUSTOMER USES EDTA SAMPLES THAT ARE SPUN FOR TWO (2) MINUTES AND THE PLASMA IS REMOVED FROM THE CELLS BEFORE RUNNING ON THE INSTRUMENT. THE CUSTOMER IS A SURGICAL UNIT THAT DOES IPTH TESTING PRIOR TO AND DURING A SURGICAL PROCEDURE. THE CUSTOMER STATED THAT THE SUBJECT SAMPLE WAS COLLECTED PRIOR TO ANY IV'S BEING ADMINISTERED TO THE PATIENT AND BOTH RESULTS CAME FROM THE SAME SAMPLE. THE TECHNICAL SUPPORT SPECIALIST (TSS) SUSPECTED FIBRIN FROM THE SUBJECT SAMPLE MAY HAVE CAUSED THE FIRST LOW RESULT. THE CUSTOMER STATED THAT THIS ISSUE HAD NEVER HAPPENED BEFORE. THE TSS TOLD THE CUSTOMER THAT THIS WAS PROBABLY AN ISOLATED EVENT, BUT TO REPORT ANY OTHER DISCREPANCIES AS THEY OCCUR. THERE IS NO INDICATION OF ANY ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282882 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1