BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 8683295 · Received June 10, 2019

    Report

    Report Number
    8031673-2019-00181
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    April 10, 2019
    Report Date
    June 10, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TOSOH LATIN AMERICA FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER ACCOUNT AND PROCEEDED TO INVESTIGATE THE REPORTED EVENT AND PERFORM PREVENTIVE MAINTENANCE (PM) ON THE AIA-900 INSTRUMENT. THE FSE FOUND SOME IRREGULARITIES WHILE PERFORMING THE PM. THE FSE NOTED THAT THE PROBE TIP WAS MISSING, AND THE B/F PROBES WERE CONSIDERABLY LOOSE. THE FSE ALSO FOUND OUT THAT THE LABORATORY WAS NOT DOING THE WEEKLY MAINTENANCE OF CLEANING THE PROBE TIPS, THEY PERFORMED ONLY MONTHLY MAINTENANCE OF REPLACING THEM COMPLETELY. THE FSE COMPLETED THE PM ON THE INSTRUMENT, PERFORMED PRECISION AND CORRELATION STUDIES; ALL TEST COMPLETED SUCCESSFULLY, AND RESULTS WERE WITHIN ACCEPTABLE RANGES. THE CUSTOMER CONFIRMED NO REOCCURRENCE OF DISCREPANT RESULTS OR ERRORS. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-900 INSTRUMENT IS FUNCTIONING AS EXPECTED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW THROUGH AWARE DATE OF EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4). THERE WERE NO OTHER SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD. THE ST AIA-PACK TSH3G ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: LIMITATIONS OF THE PROCEDURE. 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. SPECIMENS FROM PATIENTS TAKING MEDICINES AND/OR MEDICAL TREATMENT MAY SHOW ERRONEOUS RESULTS. ALL RESULTS SHOULD BE INTERPRETED WITH RESPECT TO THE CLINICAL PICTURE OF THE PATIENT. THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 11: MAINTENANCE PROVIDES DETAILED INFORMATION ON INSTRUMENT MAINTENANCE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO INSUFFICIENT PREVENTIVE MAINTENANCE (PM) BY THE TIME THE SAMPLE WAS PROCESSED, LOOSE B/F PROBE, ONE MISSING B/F PROBE TIP.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A PATIENT HAD DIFFERENT RESULTS FOR 3RD-GENERATION THYROID STIMULATING HORMONE (TSH3G) ON THE TOSOH'S AIA-900 INSTRUMENT AND ROCHE'S COBAS E411 INSTRUMENT. THE PATIENT RESULT ON THE TOSOH'S AIA-900 INSTRUMENT WAS 21.5 NG/ML AND ON THE ROCHE'S COBAS E411 INSTRUMENT WAS 1.95 NG/ML. DUE TO THE LABORATORY'S CONFIDENTIALITY, VERY LIMITED INFORMATION OF THE PATIENT WAS PROVIDED TO TOSOH. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE REPORTED EVENT. THERE WAS NO PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477750 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1