BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIA-360

    MDR report key: 5476113 · Received March 3, 2016

    Report

    Report Number
    3005529799-2016-00005
    Event Type
    Injury
    Date Received
    March 3, 2016
    Date of Event
    February 24, 2016
    Report Date
    April 13, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING CORRECTIONS WERE RECORDED IN THE PRESENT SUPPLEMENTAL MDR IN THE NOTED SECTIONS: UNK. UNK. UNK. UNK. UNK. UNK. PRODUCT PROBLEM. BLANK FIELD. N/A. N/A. SECTION C - SUSPECT PRODUCT(S) - NO. TOSOH CORPORATION. SHIBA-KOEN FIRST BUILDING. 3-8-2 SHIBA / MINATO-KU. TOKYO 1058623 JAPAN. UDI - (B)(4). HEALTH PROFESSIONAL. CRYSTAL STOLLER. JACOBSON MEMORIAL HOSP. 601 EAST STREET NORTH. ELGIN, ND 58533 USA. YES. HEALTH PROFESSIONAL. UNKNOWN. DORIA ESQUIVEL. 6000 SHORELINE COURT SUITE 101. SOUTH SAN FRANCISCO CA 94080 USA. (650)636-8123. [email protected]. 2/24/2016. FOLLOW-UP #1. 3 YEARS. OUTPATIENT DIAGNOSTIC FACILITY. TOSOH CORPORATION. SHIBA-KOEN FIRST BUILDING. 3-8-2 SHIBA / MINATO-KU. TOKYO 1058623 JAPAN. DORIA ESQUIVEL. 6000 SHORELINE COURT SUITE 101. SOUTH SAN FRANCISCO CA 94080 USA. (650)636-8123. [email protected]. TOSOH CORPORATION. SHIBA-KOEN FIRST BUILDING. 3-8-2 SHIBA / MINATO-KU. TOKYO 1058623 JAPAN. HEALTH PROFESSIONAL. 2/24/2016 PMA/510K: K971103. MALFUNCTION. CORRECTION / ADDITIONAL INFORMATION. NO / RESOLVED OVER THE PHONE / NOT RETURNED TO MANUFACTURER. 10/01/2015. NO. PATIENT CODE(S): 2692. DEVICE CODE(S): 1307. METHOD CODE(S): 10. RESULT CODE(S): 213. CONCLUSION CODE(S): 71. REUSE. THE PROBABLE CAUSE OF THE EVENT WAS SPECIMEN HANDLING. 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 (B)(4). 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 · 1

    ON (B)(6) 2016, THREE PATIENT SPECIMENS WERE ASSAYED FOR TROPONIN ON THE TOSOH AIA-360 ANALYZER. THE TESTING FOR ALL THREE SPECIMENS WAS DONE USING PRIMARY SAMPLE TUBES. THE THREE RESULTS WERE ALL POSITIVE WITH RESULTS OF 0.23 NG/ML, 0.23 NG/ML, AND 0.36 NG/ML ALL THREE PATIENTS WERE TRANSPORTED TO A LARGER MEDICAL FACILITY WHERE THE THREE PATIENTS WERE RETESTED FOR TROPONIN AND ALL THREE PATIENT RESULTS WERE NEGATIVE AT <0.06 NG/ML. THE PATIENTS WERE NOT TREATED AND WERE RELEASED. ON (B)(6) 2016, PATIENT TESTED FOR TROPONIN, PRIMARY SAMPLE TUBE USED FOR ASSAY. PATIENT RESULT 0.36 NG/ML, POSITIVE. PATIENT TRANSPORTED TO A LARGER MEDICAL FACILITY WHERE TROPONIN WAS RETESTED AND THE PATIENT RESULT WAS <0.06 NG/ML, NEGATIVE. PATIENT WAS NOT TREATED AND WAS RELEASED. ALL QCS WERE WITHIN TARGET RANGES AND THERE WERE NO ANALYZER ISSUES NOTED. ADDITIONAL TESTING SHOWED NO EVIDENCE OF REAGENT PERFORMANCE ISSUES. ROOT CAUSE: UNABLE TO DETERMINE BUT SUSPECT SPECIMEN HANDLING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134070 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1 Other