BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7387437 · Received March 30, 2018

    Report

    Report Number
    8031673-2018-04153
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    June 18, 2015
    Report Date
    March 30, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10.ADDITIONAL MANUFACTURER NARRATIVE: 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 2017-0007. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H3.DEVICE BY MANUFACTURER: ON 29-JUN-2015, AN FSE WAS DISPATCHED TO THE CUSTOMER FACILITY TO ADDRESS THE REPORTED EVENT. FSE BEGAN TO TROUBLESHOOT THE ISSUE. FSE REPLACED SPECIMEN DISPENSE SYRINGE AND VERIFIED PROPER OPERATION, THEN ADJUSTED CLOT DETECT AND VERIFIED PROPER OPERATION. THE CUSTOMER RAN QUALITY CONTROL (QC) IN WHICH ALL RESULTS WERE WITHIN ACCEPTABLE RANGE AND VERIFIED THAT THE ANALYZER WAS FUNCTIONING CORRECTLY. THE AIA-900 ANALYZER WAS FUNCTIONING AS INTENDED AND THE ERRORS CLEARED. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE PROBABLE CAUSE OF THE EVENT WAS SAMPLE SYRINGE FAILURE.

    Description of Event or Problem · 0

    ON (B)(6) 2015, A CUSTOMER REPORTED SAMPLING LOW RESULTS WITH THEIR AIA-900 ANALYZER. CUSTOMER STATED THAT PREVENTIVE MAINTENANCE WAS RECENTLY PERFORMED BUT FORGOT TO MENTION THAT 3 TIMES SHE WOULD GET A FT4 RESULT OF <L AND WHEN REPEATED THE VALUE WOULD BE .9 OR 1.0, WHICH IS NORMAL. CUSTOMER THEN INFORMED THAT THIS FIRST OCCURRED 2 MONTHS AGO BUT DID NOT HAVE SPECIFIC DATA WHEN ASKED. TSS ADVISED TO RUN A PRECISION STUDY, N=20 ON L1 QC TO CHECK FOR SAMPLING. CUSTOMER SENT PRECISION DATA FOR REVIEW. PRECISION, N=20, MEAN 1.585, CV 4.7%. ON 19-JUN-2015, TECHNICAL SUPPORT SPECIALIST (TSS) CALLED CUSTOMER TO PROVIDE HER WITH THE RESULTS OF HER PRECISION STUDY. CUSTOMER REPORTED THAT SHE RECEIVED ANOTHER <L FT4 WHICH WAS REPEATED AND THE RESULT WAS NORMAL. THE REPEATED VALUES DID CORRELATE WITH THE PATIENT'S CLINICAL HISTORY AND TSH RESULT WHICH THEN WAS REPORTED OUT. NO CORRECTIVE REPORTS WERE NECESSARY. (B)(6). THE SPECIMEN WAS BARCODED AND CUSTOMER PROVIDED THE PRINTOUTS. CUSTOMER DOES USE SST TUBES, ALLOWS 20-30 MINUTES FOR CLOT TO FROM, SPINS 10 MIN @ 3300 RPM, POURS SERUM OFF IMMEDIATELY. THE SPECIMEN IS NEVER RUN IN THE PRIMARY TUBE. THE CUSTOMER IS UNABLE TO RUN FT4, TSH, AND PTH PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING FT4, TSH, AND PTH PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229875 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1