BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 8049340 · Received November 7, 2018

    Report

    Report Number
    8031673-2018-05256
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Date of Event
    September 20, 2018
    Report Date
    November 7, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. A 13-MONTH COMPLAINT / SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER 11086810 FROM AWARE DATE OF 20 SEPT 2018, WHICH INCLUDED DATA FROM 20 AUG 2017 THROUGH 20 SEPT 2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD, WHICH INCLUDES THIS EVENT. THE AIA-PACK TSH 3RD-GEN ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: SAMPLES MAY BE STORED AT 2° - 8° C FOR UP TO 24 HOURS PRIOR TO ANALYSIS. IF THE ANALYSIS CANNOT BE DONE WITHIN 24 HOURS, THE SAMPLE SHOULD BE STORED FROZEN AT -20°C OR BELOW FOR UP TO 60 DAYS. REPEATED FREEZE-THAW CYCLES SHOULD BE AVOIDED. TURBID SERUM SAMPLES OR SAMPLES CONTAINING PARTICULATE MATTER SHOULD BE CENTRIFUGED PRIOR TO TESTING. PRIOR TO ASSAY, SLOWLY BRING FROZEN SAMPLES TO ROOM TEMPERATURE (18° - 25° C) AND MIX GENTLY. THE MOST PROBABLE CAUSE FOR THE REPORTED EVENT WAS OPERATOR ERROR. THIS IS A CORRECTION TO THE MFR REPORT #: 8031673-2018-00899 AND UF/IMPORTER REPORT #: 3005529799-2018-00899 SUBMITTED ON 19-OCT-2018. TOSOH IDENTIFIED THAT MFR REPORT #: 8031673-2018-00899 AND UF/IMPORTER REPORT #: 3005529799-2018-00899 HAD ALREADY BEEN ASSIGNED TO A DIFFERENT EVENT, WHICH WAS SUBMITTED WITH THE AGENCY ON 09-OCT-2018. NEW MFR. REPORT #8031673-2018-05256 AND UF/IMPORTER REPORT #3005529799-2018-05256 HAVE BEEN ASSIGNED TO THE MFR REPORT #: 8031673-2018-00899 AND UF/IMPORTER REPORT #: 3005529799-2018-00899 SUBMITTED ON 19-OCT-2018 TO CORRECT THE ERROR.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THREE (3) OF THE FIVE (5) (B)(6) SURVEY SAMPLES FOR PROFICIENCY TESTING ON THYROID STIMULATING HORMONE (TSH) WERE UNACCEPTABLE ON THEIR AIA-900 INSTRUMENT. SAMPLE, ACTUAL RESULT, EXPECTED RANGE: (B)(6), 13.84 ULU/ML, 10.08 ULU/ML - 12.87 ULU/ML. (B)(6), 20.95 ULU/ML, 14.56 ULU/ML - 20.02 ULU/ML. THE TECHNICAL SUPPORT SPECIALIST (TSS) REVIEWED THE QUALITY CONTROL (QC) DATA FOR THE MONTH OF (B)(6) 2018. THE QC DID NOT DEVIATE FROM THE TOSOH TARGET VALUES MEANS AND STAYED WITHIN +/- 1 STANDARD DEVIATION; QC WAS WITHIN ACCEPTABLE RANGE. THE TSS REVIEWED THE CALIBRATION CURVE AND WAS CONFIRMED TO BE WITHIN ACCEPTABLE RANGE. THE (B)(6) SURVEY SAMPLES HAVE 14-DAY STABILITY AT 2 - 8 DEGREES CELSIUS. THE (B)(6) SURVEY SAMPLES WERE OPENED PAST OPEN STABILITY AT 54-DAYS. THE TSS REVIEWED THE PLOT OF RELATIVE DISTANCE OF RESULTS FROM TARGET AS PERCENTAGE OF ALLOWED DEVIATION. ONE (1) RESULT WAS >75%, WHICH IS INDICATED OF A CLERICAL ERROR. THERE WAS NO +/- BIAS, WHICH INDICATED NO SYSTEMATIC ERROR. THE CUSTOMER WAS ADVISED TO INVESTIGATE THE CLERICAL ERROR, BUT THE AIA-900 INSTRUMENT RUN TAPE WAS NOT AVAILABLE. THE CUSTOMER AGREED TO FREEZE ALL FUTURE SURVEY SAMPLES FOR RETESTING. NO FURTHER ACTION WAS REQUIRED BY THE TSS. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886050 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1