BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-600II

    MDR report key: 7267672 · Received February 13, 2018

    Report

    Report Number
    3005529799-2018-01104
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    October 16, 2017
    Report Date
    October 19, 2018
    Manufacturer
    TOSOH BIOSCIENCE
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. THIS REPORT IS BEING SUBMITTED DUE TO AN INTERNAL NONCONFORMANCE IDENTIFIED. ON (B)(6) 2017, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. THE FSE ADVISED THE CUSTOMER ON HOW TO CLEAN OUT THE AIA-600II SYSTEM. THE AIA-600II INSTRUMENT IS OPERATIONAL AND NO FURTHER ACTION IS REQUIRED BY FIELD SERVICE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2016 THROUGH (B)(6) 2017 FOR SIMILAR COMPLAINTS WAS PERFORMED. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-600II OPERATOR'S MANUAL UNDER SECTION 9 MAINTENANCE IS AS FOLLOWS: MAINTENANCE IS ESSENTIAL TO THE RELIABLE PERFORMANCE OF THE AIA-600 II. PROPER MAINTENANCE IS ONE OF THE MOST IMPORTANT ASPECTS OF A COMPLETE QUALITY ASSURANCE PROGRAM. COMPLETING THE REQUIRED MAINTENANCE PROCEDURES, MINIMIZES DOWN TIME, PROVIDES RECORDS FOR INSPECTION AND ACCREDITATION, PROVIDES ASSISTANCE IN THE DEFINITION AND ISOLATION OF PROBLEMS, AND MAINTAINS OPTIMAL INSTRUMENT AND ASSAY PERFORMANCE. 9.1 DAILY MAINTENANCE, 9.2 WEEKLY MAINTENANCE, 9.3 MONTHLY MAINTENANCE, 9.4 AS NEEDED MAINTENANCE. THE MOST PROBABLE CAUSE FOR THE LOW RECOVERY ON THE E2 WAS THE AIA-600II NEEDED TO BE FLUSHED TO CLEAN OUT THE SYSTEM.

    Additional Manufacturer Narrative · 0

    (B)(4), 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. CORRECTION: UPDATED APPROXIMATE AGE OF DEVICE, DEVICE MFG DATE.

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED THE BIO RAD ON THE QUALITY CONTROL FOR THE E2 REPRODUCTIVE HORMONE WAS RECOVERING LOW ON THE AIA-600II INSTRUMENT. THE CUSTOMER WAS UNAWARE IF THEY EVER PERFORMED A MAINTENANCE BASED ON THE DECONTAMINATION PROCEDURE. TECHNICAL SUPPORT ADVISED THE CUSTOMER TO DECONTAMINATE THE SYSTEM THEN TO RECALIBRATE. ON (B)(6) 2017, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF CONTROL RESULTS FOR E2. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110804 AIA-600II AIA-600II KHO TOSOH BIOSCIENCE AIA-600II

    Patients

    Seq Age Sex Outcome Treatment
    1