BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 8192990 · Received December 22, 2018

    Report

    Report Number
    8031673-2018-05352
    Event Type
    Malfunction
    Date Received
    December 22, 2018
    Date of Event
    November 30, 2018
    Report Date
    January 21, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE LIQUID SENSE GROUND CABLE AND PRESSURE SENSOR WERE RETURNED AND EVALUATED, THE INVESTIGATION CONCLUDED THAT THE REPORTED ISSUE WAS RELATED TO THE CUSTOMER USING THE INCORRECT TUBES, AND NOT ANY MALFUNCTION OF THE DEVICE AND/ OR RETURNED PART. 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.

    Additional Manufacturer Narrative · 0

    ONE LIQUID SENSE GROUND CABLE AND PRESSURE SENSOR WERE RETURNED FOR EVALUATION TO THE TOSOH INSTRUMENT SERVICE CENTER (ISC) WITH NO SHIPPING DAMAGE. THE LIQUID SENSE GROUND CABLE AND PRESSURE SENSOR PASSED FUNCTIONAL TESTING. THE REPORTED EVENT WAS NOT DUPLICATED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS DUE TO OPERATOR ERROR, IMPROPER USE OF 12 MM POUR OFF TUBES. 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.

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. FSE ARRIVED AT THE SITE TO ADDRESS THE REPORTED EVENT. FSE CONFIRMED THE ERRORS VIA THE ERROR LOG AND REPRODUCED THE ERROR WITH MULTIPLE RUNS AND DIFFERENT SAMPLES. NEXT, FSE VERIFIED THE CUP/TUBE DETECTOR OPERATED WITH NO ISSUES. THE FSE THEN PROCEEDED TO REPLACE THE SAMPLE NOZZLE, GROUND WIRE, AND S206 PRESSURE SENSOR PROACTIVELY, AND VERIFIED THE LIQUID LEVEL SENSE AND CLOT DETECTION ADJUSTMENTS. THE FSE CONFIRMED THAT THE CUSTOMER USED BOTH 12 MM TUBES AND 13 MM TUBES FOR TESTING. THE 12 MM TUBES ARE NOT APPROVED FOR THE TOSOH SYSTEM AND CONTRIBUTED TO THE INTERMITTENT INCONSISTENT TSH PATIENT RESULTS. THE CUSTOMER SENT DISCREPANT PATIENT RESULTS TO THE ASSOCIATED HOSPITAL REFERENCE LAB TO CONFIRM PATIENT RESULTS. TOSOH WAS NOT PROVIDED WITH SPECIFIC DETAILS ON ADDITIONAL PATIENT DISCREPANT RESULTS BESIDES THE ONE THAT WAS ALREADY DESCRIBED. THE FSE CALIBRATED THE INSTRUMENT TO THE 13 MM TUBES AND ADVISED THE CUSTOMER THAT 12 MM SAMPLE TUBES ARE NOT COMPATIBLE WITH THE ANALYZER. THE FSE VERIFIED QC IN BOTH SAMPLES CUPS AND 13 MM TUBES, WHICH WERE WITHIN ACCEPTABLE RANGE. THE AIA-360 INSTRUMENT PERFORMED WITHIN MANUFACTURER'S SPECIFICATIONS; NO FURTHER ACTION WAS REQUIRED. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(6) FROM 30OCT2017 THROUGH AWARE DATE (B)(4) 2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE TSH ST AIA-PACK PACKAGE INSERT STATES THE FOLLOWING: SPECIMEN COLLECTION AND HANDLING: SERUM IS REQUIRED FOR THE ASSAY. EDTA AND CITRATED PLASMA SHOULD NOT BE USED. NO SPECIAL PATIENT PREPARATION IS NECESSARY. A VENOUS BLOOD SAMPLE IS COLLECTED ASEPTICALLY WITHOUT ADDITIVES (RED TOP TUBE). STORE AT ROOM TEMPERATURE UNTIL A CLOT HAS FORMED (USUALLY 15-45 MINUTES), THEN CENTRIFUGE TO OBTAIN THE SERUM SPECIMEN FOR ASSAY. SST OR GEL TUBES HAVE NOT BEEN VALIDATED. 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. ALL SAMPLES REQUIRE PRETREATMENT. PRETREATED SAMPLES SHOULD BE ASSAYED WITHIN ONE HOUR AFTER COMPLETION OF THE PRETREATMENT PROCEDURE. THE PRETREATED SAMPLE REQUIRED FOR ANALYSIS IS 100 [?]L. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS DUE TO IMPROPER USE OF 12 MM POUR OFF TUBES.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED TO REPORT RECEIVING INCONSISTENT THYROID-STIMULATING HORMONE (TSH) PATIENT RESULTS ON THEIR AIA-360 ANALYZER. THE CUSTOMER STATED THAT THEY HAD NOTIFIED THE FIELD SERVICE ENGINEER (FSE) THAT HAD BEEN ON SITE PERFORMING PERIODIC MAINTENANCE (PM) THE WEEK PRIOR OF THE ISSUES THEY WERE HAVING. AT THAT TIME, FSE MADE SOME ADJUSTMENTS TO THE SAMPLING, WHICH SEEMED TO HELP INITIALLY. LATER THAT WEEK, THE CUSTOMER NOTED THAT A THYROID-STIMULATING HORMONE (TSH) SAMPLE WAS RUN IN A TUBE AND THE RESULT WAS 4.3 ULU/ML. THE RESULT SEEMED OFF SO THEY REPEATED IT IN A CUP AND RECEIVED A RESULT OF 7.2 ULU/ML. THE CUSTOMER THEN TRIED RUNNING OTHER SAMPLES FIRST IN THE TUBE AND THEN IN THE CUP AND ALL THE SAMPLES RESULTS WERE DIFFERENT. THE TECHNICAL SUPPORT SPECIALIST (TSS) REQUESTED INFORMATION REGARDING NUMBER OF SAMPLES POSSIBLY IMPACTED. THE CUSTOMER STATED THAT THEY WERE LOW VOLUME AND ONLY ABOUT TWENTY SAMPLES MAY HAVE BEEN AFFECTED. A FIELD SERVICE ENGINEER WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032209 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1