BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 6953199 · Received October 16, 2017

    Report

    Report Number
    8031673-2017-00055
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    September 18, 2017
    Report Date
    October 25, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THIS MDR MFR REPORT #: 8031673-2017-00055 / IMPORTER REPORT #: 3005529799-2017-00063 WAS PREVIOUSLY SUBMITTED TO THE FDA ON 28DEC2017; IT WAS RECREATED AS MFR REPORT #: 8031673-2017-00055 PER REQUEST BY THE FDA MDR DATA SYSTEMS TEAM REPRESENTATIVE. 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. CORRECTED DATA: SECTION G2: CHECKED "HEALTH PROFESSIONAL" AS REPORT SOURCE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: A COMPLAINT HISTORY REVIEW FOR SERIAL NUMBER (B)(4) WAS PERFORMED FROM 18-AUG-2016 THROUGH 18-SEP-2017 FOR SIMILAR COMPLAINTS. NO OTHER SIMILAR COMPLAINTS WERE IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-360 OPERATOR'S MANUAL UNDER CHAPTER 2 - 4. INSTALLATION PROCEDURES STATES TO USE THE COLOR CODING FOR THE LEVEL SENSOR LEAD WIRES TO ENSURE THAT THEY ARE CORRECTLY CONNECTED TO THE ELECTRODES FOR EACH BOTTLE. GREEN FOR THE DILUENT BOTTLE AND YELLOW FOR THE WASH SOLUTION BOTTLE. CHAPTER 4-1, PRIOR TO COMMENCING OPERATION, RECOMMENDS MAKING SURE TO PROPERLY MIX THE SUBSTRATE, DILUENT AND WASH SOLUTIONS IN ACCORDANCE WITH INSTRUCTIONS PROVIDED IN THE MANUAL. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THE ISSUE WAS RESOLVED BY REPLACING THE WASH DILUENT AND WASH SOLUTION BOTTLES.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED BEING UNABLE TO PASS QUALITY CONTROLS (QC); THEREFORE, COULD NOT RUN PATIENT SAMPLES FOR TROPONIN ON THE AIA-360 ANALYZER. THE CUSTOMER REPORTED THAT THE ISSUE BEGAN ON (B)(6) 2017 EVEN AFTER REPLACING THE WASH DILUENT AND WASH SOLUTION BOTTLES ON THE AIA-360. THE CUSTOMER STATED THAT A SECOND AIA-360 WAS EXPERIENCING A SIMILAR ISSUE AS WELL. THE TECHNICAL SUPPORT SPECIALIST SUGGESTED TO THE CUSTOMER TO INSTALL NEW WASH DILUENT AND WASH SOLUTION BOTTLES, PRIME, AND THEN RE-CALIBRATE THE AIA-360 ANALYZER. THE CUSTOMER REPORTED THAT ISSUE AFTER INSTALLING NEW WASH DILUENT AND WASH SOLUTION BOTTLES. THE CUSTOMER WAS UNABLE TO DETERMINE WHICH ONE WAS CAUSING THE REPORTED ISSUES SINCE BOTH WERE MADE AND PRIMED INTO THE SYSTEM AT THE SAME TIME. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS FOR TROPONIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731778 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown