BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIA-1800

    MDR report key: 5640396 · Received May 9, 2016

    Report

    Report Number
    3005529799-2016-00007
    Event Type
    Injury
    Date Received
    May 9, 2016
    Date of Event
    April 10, 2016
    Report Date
    April 13, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING CORRECTIONS WERE RECORDED IN THE PRESENT SUPPLEMENTAL MDR IN THE NOTED SECTIONS: PATIENT IDENTIFIER, AGE OR DATE OF BIRTH, PATIENT SEX, WEIGHT, ETHNICITY, RACE: UNK. SUSPECT PRODUCT(S) - NO. MANUFACTURER NAME, CITY AND STATE - TOSOH CORPORATION. SHIBA-KOEN FIRST BUILDING, 3-8-2 SHIBA, MINATO-KU. TOKYO, 1058623, JAPAN MODEL # - AIA-1800; CATALOG # - 019836; UDI - (B)(4). OPERATOR OF DEVICE - HEALTH PROFESSIONAL. INITIAL REPORTER OCCUPATION - HEALTH PROFESSIONAL. USER FACILITY OR IMPORTER NAME AND ADDRESS -(B)(6). TYPE OF REPORT - FOLLOW-UP #1. APPROXIMATE AGE OF DEVICE - 8 YEARS. LOCATION WHERE EVENT OCCURED - (B)(6) FACILITY. MANUFACTURER NAME AND ADDRESS - TOSOH CORPORATION. SHIBA-KOEN FIRST BUILDING; 3-8-2 SHIBA, MINATO-KU, TOKYO ,1058623, JAPAN. CONTACT NAME AND ADDRESS - (B)(6). REPORT SOURCE- HEALTH PROFESSIONAL. DATE RECEIVED BY MANUFACTURER - 4/15/2016. PMA/510K - K971103. TYPE OF REPORTABLE EVENT - MALFUNCTION. IF FOLLOW-UP, WHAT TYPE - CORRECTION / ADDITIONAL INFORMATION. DEVICE EVALUATED BY MFR - NO / RESOLVED OVER THE PHONE / NOT RETURNED TO MANUFACTURER. DEVICE MANUFACTURE DATE - 07/01/2008. LABELED FOR SINGLE USE? - NO. PATIENT CODE(S): 2692; DEVICE CODE(S): 2379 - 2913; METHOD CODE(S): 3263; RESULT CODE(S): 3221; CONCLUSION CODE(S): 67. USAGE OF DEVICE - REUSE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS UNKNOWN, BUT MAY BE RELATED TO SPECIMEN CLOTTING ISSUES. 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). 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 04/15/2016 TOSOH BIOSCIENCE, INC. WAS NOTIFIED OF AN ISSUE WITH A BETA HCG (BHCG) SPECIMEN THAT WAS ASSAYED ON (B)(6) AT 10:51 AM AFTER A SAMPLE WAS FLAGGED AS CLOTTED. A SAMPLE FOR ESTRADIOL, PROGESTERONE, AND BHCG WAS RUN AND FLAGGED AS CLOTTED WHICH INDICATES THAT THE RESULT COULD BE INCORRECT AND SHOULD BE REPEATED. THE NEXT SAMPLE ASSAYED WAS A BARCODED PRIMARY TUBE FOR BHCG THAT GAVE A "DILUTION NEEDED" (DO) RESULT. THE OPERATOR REPEATED THE SAME SAMPLE AT A 1:50 DILUTION INSTEAD OF THE RECOMMENDED DILUTION OF 1:100 FOR A DO. THE 1:50 DILUTED SPECIMEN HAD A RESULT OF 501.6. THE PATIENT LATER WENT TO THE ER WHERE A RESULT OF >6000 WAS REPORTED. THE SAMPLE WAS FROZEN AND READ THE NEXT DAY WITHOUT A BARCODE. DILUTIONS WERE DONE AT 1:10, 1:50, AND 1:100. THE 1:10 GAVE A >HIGH RESULT, THE 1:50 DILUTION GAVE A RESULT OF 6418.5, THE 1:100 SAMPLE GAVE A RESULT OF 6578.7. THE SAMPLE WAS RUN AT ANOTHER FACILITY AND GAVE A RESULT OF 6000. OTHER PATIENT SPECIMENS WERE RETESTED THE FOLLOWING DAY AND NO ADDITIONAL ERRORS WERE FOUND. ROOT CAUSE: UNKNOWN, PARTIAL CLOT (NOT TOTAL OR CLOT DETECTION FLAG WOULD HAVE OCCURRED) ON THE ORIGINAL 1:50 DILUTION IS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295507 AIA-1800 AIA-1800 KHO TOSOH CORPORATION AIA-1800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other