BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7385926 · Received March 30, 2018

    Report

    Report Number
    3005529799-2018-03716
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    September 9, 2016
    Report Date
    April 20, 2018
    Manufacturer
    TOSOH BIOSCIENCE, INC.
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-(B)(4). FSE WAS DISPATCHED AND ON 12-SEPT-2016 DISCOVERED MOTOR NOT DRIVING MAIN ARM Y AXIS, VERIFIED HOME SENSORS ARE FUNCTIONING PROPERLY. ORDERED MOTOR AND CABLE. ON (B)(6) 2016 REPLACED Y AXIS MOTOR AND CABLE, VERIFIED PROPER OPERATION AND ALIGNMENTS. UPDATED SOFTWARE TO VERSION 2.02. CUSTOMER RAN QC (QUALITY CONTROL) WHICH PASSED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS Y AXIS PULSE MOTOR FAILURE.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT # 1 FOR MDR 2018-03716 (MFR) FILED FOR "DATE OF REPORT: DESCRIBE EVENT OR PROBLEM" CORRECTION TO: "ON (B)(6) 2016 THE CUSTOMER REPORTED MAIN ARM Y AXIS HOME DETECT ERROR 4211 WITH THEIR AIA-2000 ANALYZER. TS (TECHNICALSUPPORT) ASSISTED CUSTOMER IN PERFORMING VERSION UP BUT THE SAME ERROR WAS NOTED. THE CUSTOMER IS UNABLE TO RUN E2, LHII, FSH, BHCG, PROG III AND PRL PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING E2, LHII, FSH, BHCG, PROG III AND PRL PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING."

    Description of Event or Problem · 0

    ON (B)(6) 2016 THE CUSTOMER REPORTED MAIN ARM Y AXIS HOME DETECT ERROR 4211 WITH THEIR AIA-2000 ANALYZER. TS (TECHNICAL SUPPORT) ASSISTED CUSTOMER IN PERFORMING VERSION UP BUT THE SAME ERROR WAS NOTED. THE CUSTOMER IS UNABLE TO RUN HBA1C PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING HBA1C PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228759 AIA-2000 AIA-2000 KHO TOSOH BIOSCIENCE, INC. AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1