BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7488994 · Received May 4, 2018

    Report

    Report Number
    8031673-2018-00386
    Event Type
    Malfunction
    Date Received
    May 4, 2018
    Date of Event
    April 6, 2018
    Report Date
    December 18, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CJ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018 FOR SIMILAR COMPLAINTS WAS PERFORMED. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-360 SERVICE MANUAL UNDER SECTION 1-2 TROUBLESHOOTING INSTALLATION AND STARTUP ERRORS STATES: 1.2.1.4: KEY IS NOT FUNCTIONING PROPERLY CONFIRM THAT CONNECTORS ARE PROPERLY INSTALLED ON THE KEYS CHECK KEY HARNESS FOR FAULTY SOLDERING. IN ADDITION, THE OPERATOR'S MANUAL ALSO STATES: DO NOT DEPRESS THE START KEY FOR A LONG TIME. DEPRESSING THE START KEY FOR A LONG TIME (ABOUT TWO SECONDS OR LONGER) SENDS AN ABORT REQUEST FOR AN EMERGENCY STOP AND PRINTS A WARNING MESSAGE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO LOOSE KEY PANEL CONNECTORS.

    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

    THIS FOLLOW-UP #2 IS FOR A CORRECTION IN THE PREVIOUSLY SUBMITTED FOLLOW-UP #1 WHERE THE DATES IN THESE SECTIONS WERE INCORRECT. 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

    ADDITIONAL INFORMATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR SERIAL NUMBER (B)(4) WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THE KEY PANEL WAS NOT RESPONDING TO INPUT ON THE AIA-360 INSTRUMENT. CUSTOMER IS UNABLE TO RUN PATIENT SAMPLES ON ALPHA-FETOPROTEIN (AFP), BETA HUMAN CHORIONIC GONADOTROPIN (BHCG), CREATINE KINASE MB ISOENZYME (CK-MB), CARDIAC TROPONIN I (CTNL 2), FOLLICLE STIMULATING HORMONE (FSH), INTACT PARATHYROID HORMONE (IPTH), MYOGLOBIN (MYO), PROLACTIN (PRL), AND PROGESTERONE (PROG II). THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS. THE CUSTOMER REPORTED THEY TURNED OFF THE INSTRUMENT TO TROUBLESHOOT. CUSTOMER REMOVED THE BACK PANEL COVER, IDENTIFIED THE CABLES THAT CONNECT THE KEY PANEL TO THE INTERNAL CONNECTORS, TIGHTEN THE CABLES, AND REPLACED THE COVER. THE INSTRUMENT WAS TURNED ON AND THE KEY PANEL WAS RESPONDING TO MANUAL INPUTS. THE AIA-360 INSTRUMENT IS FUNCTIONING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330481 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1