BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSOH AIA-900

    MDR report key: 6170774 · Received December 13, 2016

    Report

    Report Number
    3005529799-2016-00017
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 14, 2016
    Report Date
    April 11, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CONTACT OFFICE: (B)(6).US TELEPHONE: (B)(6). MANUFACTURING SITE: TOSOH CORPORATION (MANUFACTURER) SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA MINATO-KU, TOKYO 1058623, JA. DATE REC¿D BY MFR:HEALTH PROFESSIONAL. (B)(6) 2016. PMA/510K:510K: K971103. ON (B)(6) 2016, FSE ARRIVED AT THE SITE TO ADDRESS THE REPORTED EVENT. FSE REMOVED A WASH PROBE TIP FROM THE WASHINGTON. WELL, AND REPLACED THE WASH SYRINGE AND SEALS. FSE ALSO CLEANED THE DETECTOR LENS, THEN PRIMED AND RAN DAILY CHECKS. NO FURTHER ERRORS WERE NOTED. ON (B)(6) 2016, THE MANUFACTURER WAS NOTIFIED OF ERRONEOUS RESULTS THAT HAD BEEN REPORTED. THE FOLLOWING CHART LISTS THE RESULTS AND SUBSEQUENT CORRECTIONS. ACCESSION # INITIAL RESULT REPEAT RESULT ANALYTE COMMENT 162910274 233 181 CA125 RESULT CHANGED 162980224 729 61.4 CA125 RESULT CHANGED 153480472 11.2 8.8 CA27-29 RESULT CHANGED, 161440474 48.5 30.93 CA27-29, RESULT CHANGED 162240440 147 91.3 , FERRITIN RESULT CHANGED 163120121 <0.10 1.52 FREE, T4 RESULT CHANGED 162980204 <0.10 0.83 FREE, T4 RESULT CHANGED 162910301 56.92 1.29 PSA RESULT CHANGED. NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAULT/ FAILURE OF THE WASH PUMP. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, 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.

    Description of Event or Problem · 0

    ON (B)(6)2016, THE CUSTOMER CALLED TO REPORT THAT FOLLOWING A B/F PROBE MAINTENANCE PROCEDURE, THEY WERE RECEIVING HIGH FLAGS ON ALL SAMPLES AND QUALITY CONTROL (QC) WITH THEIR A1A-900 ANALYZER. ON (B)(6) 2016, FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DISCREPANT PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Description of Event or Problem · 1

    ON 11/14/2016 TOSOH BIOSCIENCE WAS NOTIFIED THAT FOLLOWING A BF PROBE MAINTENANCE PROCEDURE, THE CUSTOMER WAS RECEIVING FLAGS FOR HIGH (EXCEEDING THE HIGH END OF THE CURVE) RESULTS. ON THIS DATE, THERE WERE NO REPORTS OF ERRONEOUS PATIENT RESULTS DURING THE PHONE NOTIFICATION. TOSOH BIOSCIENCE FIELD SERVICE ENGINEER WAS DISPATCHED AND FOUND A WASH PROBE TIP IN THE WASHING WELL. THE WASH SYRINGE SEALS WERE ALSO DETERMINED TO NEED REPLACED. REPAIRS WERE COMPLETED AND THE ANALYZER WAS WORKING AS EXPECTED. ON 11/21/2016 TOSOH BIOSCIENCE WAS NOTIFIED THAT ERRONEOUS RESULTS HAD BEEN REPORTED. (B)(6). ROOT CAUSE: WASH FUNCTION WAS NOT WORKING AS REQUIRED BECAUSE WASH PROBE TIP HAD FALLEN OFF AND SYRINGE SEALS WERE WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822545 TOSOH AIA-900 A1A-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1 Other