BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1A-900

    MDR report key: 7372447 · Received March 26, 2018

    Report

    Report Number
    8031673-2018-04270
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Date of Event
    May 15, 2015
    Report Date
    March 26, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K0971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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-2017-0007. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. ON 01-JUN-2015, ARRIVED AT THE SITE TO ADDRESS THE REPORTED EVENT. FSE CHECKED THE DILUENT AND WASH SYSTEM FOR LEAKS, BUT NONE WERE FOUND. NEXT, HE ADJUSTED THE B/F WASH PROBE POSITIONS AT THE INCUBATOR AND RAN PRECISON FOR TROPONIN WITH LOT 45. BOTH QC AND PRECISION RESULTS WERE WITHIN RANGE. NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT DUE TO MISALIGNMENT OF THE WASH PROBES AT THE INCUBATOR.

    Description of Event or Problem · 0

    ON (B)(6) 2015 THE CUSTOMER REPORTED QUALITY CONTROL (QC) ISSUES WITH CTNI ON THEIR A1A-900. TECHNICAL SUPPORT INSTRUCTED THE CUSTOMER TO PERFORM A PRECISION TEST ON QC LEVEL 2 AND A PATIENT SAMPLE. THE RESULTS RETURNED LOW. TS ASKED THE CUSTOMER TO FAX QC RESULTS FOR THE PAST 90 DAYS TO SEE IF THE ISSUE COINCIDED WITH ANY CHANGES OF SUBSTRATE, WASH, DILUENT; OR ENVIRONMENTAL CHANGES. ON (B)(6) 2015, TS LEFT A VOICEMAIL TO FOLLOW UP WITH THE CUSTOMER. ON (B)(6) 2015, TS RECEIVED AND REVIEWED THE CUSTOMER'S QC DATA. REVIEW OF MAY'S DATA REVEALED THAT QC WAS RUNNING ONE STANDARD DEVIATION (SD) BELOW THE MEAN FOR MOST OF THE MONTH, WITH TWO OUTLIERS RUNNING ONE SD & TWO SD'S ABOVE THE MEAN. ON (B)(6) 2015, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR CTNI. 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
    215237 A1A-900 A1A-900 KHO TOSOH CORPORATION A1A-900

    Patients

    Seq Age Sex Outcome Treatment
    1