BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7431939 · Received April 16, 2018

    Report

    Report Number
    8031673-2018-01207
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Date of Event
    August 6, 2015
    Report Date
    February 17, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS DISPATCHED TO THE FIELD SERVICE ENGINEER (FSE) DEPARTMENT ON (B)(6) 2015 FOR FURTHER INVESTIGATION. DURING THE INVESTIGATION THE FSE FOUND THE HYBRID ARM NOZZLE HITTING THE WASTE TIP DISCARD PLATE. AN ALIGNMENT ON THE HYBRID ARM AND MULTIPLE TIP ATTACH/DISCARD MACROS WERE PERFORMED WITHOUT ANY ERRORS. ALSO, THE FSE FOUND A BAD TIP BOX THAT WAS CAUSING THE ANALYZER TO SKIP TIPS. THE BOX WAS WRAPPED AND THROWN AWAY. FSE PERFORMED SORTER TIP ALIGNMENT AND WAS COMPLETED WITHOUT ANY ERRORS. THEN FSE RAN ALL 4 CORNERS TIP MACROS PROCEDURE WITHOUT ANY ERRORS. INSTRUMENT IS FUNCTIONING AS INTENDED AND WAS RELEASED. A 13 MONTH COMPLAINT/ SERVICE HISTORY REVIEW FOR SERIAL NUMBER (B)(4) WAS PERFORMED AND FOUND ONE OTHER COMPLAINT WITH SIMILAR EVENT. THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS MISALIGNED HYBRID ARM NOZZLE. 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).

    Description of Event or Problem · 0

    ON (B)(6) 2015 THE CUSTOMER REPORTED ERROR 2101 TIP DETACHMENT FAILURE BY HYBRID ARM AND SKIPS TIPS IN TRAY. CUSTOMER REQUESTED SERVICE IN ORDER TO ADDRESS THE REPORTED ISSUE WHICH RESULTED IN DELAYED REPORTING OF RESULTS FOR BHCG FSH, E2, PTH, PRL AND LH II. THERE WAS 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
    275286 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1