BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7273543 · Received February 15, 2018

    Report

    Report Number
    8031673-2018-01402
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    September 10, 2015
    Report Date
    February 15, 2018
    Manufacturer
    TOSOH CORPORATION
    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

    H10 ADDITIONAL NARRATIVE: THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-2017-0007. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 11 SEP 2015. THE FSE RESEATED WIRES TO THE STC LANE MOTOR AND SENSOR THEN LUBRICATED THE STC MOTOR SLIDE AND STC X AXIS . THE SORTER TO THE STC (STC LANE MIXING) LANE CUP WAS OUT OF ADJUSTMENT IN THE X AXIS, THE FSE CORRECTED THE ADJUSTMENT ENABLING THE CUP TO GO INTO THE STC LANE SMOOTHLY. RAN ALL CONTROLS WITH B12, FOLATE AND VITAMIN D WITHOUT PROBLEMS. THE AIA-2000 INSTRUMENT WAS FUNCTIONING AS INTENDED. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. AIA 2000 INSTRUMENT WAS FUNCTIONING AS INTENDED. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE PROBABLE CAUSE OF THE EVENT WAS MISALIGNMENT OF THE SORTER TO THE STC LANE. A COMPLAINT HISTORY REVIEW FOR SERIAL NUMBER (B)(4) WAS CONDUCTED FROM 10-AUG-2014 THROUGH (B)(4) 2015 FOR SIMILAR COMPLAINTS. THERE WERE TWO (2) COMPLAINTS REPORTED DURING THIS TIME PERIOD SIMILAR TO THE PRESENT ISSUE.

    Description of Event or Problem · 0

    ON (B)(6) 2015 A CUSTOMER REPORTED ERROR 3061 (STC LANE MIXING) AND 2151 (HYBRID ARM-CUP TRANSFER FAILURE) WITH THEIR AIA-2000. THE CUSTOMER WAS UNABLE TO RUN PATIENT SAMPLES ON LHII A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 11 SEP 2015 TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF LHII PATIENT RESULTS. THERE WAS NOT INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE EVENT CONSEQUENCE DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118130 AIA-2000 AIA-2000, PRODUCT CODE: KHO KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1