BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 8338985 · Received February 14, 2019

    Report

    Report Number
    8031673-2019-00025
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    January 16, 2019
    Report Date
    July 26, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION PERFORMED BY (B)(6) CONFIRMED THAT THE CUSTOMER HAD AN OVERALL EXCELLENT PERFORMANCE, WITH THE EXCEPTION OF ESTRADIOL (E2). NO ISSUE WAS SEEMED WITH THE REPORTING UNIT (CUSTOMER HAD PROVIDED THE (B)(6) ANALYZER PRINTOUT THAT MATCHED THE ENTERED RESULT AND UNIT). ACCORDING TO THE CUSTOMER, QC WAS WITHIN REQUIRED SPECIFICATIONS. IT WAS OBSERVED THAT PARTICIPANTS FROM LATIN AMERICA AND CENTRAL AMERICA, OTHER THAN URUGUAY, USING THE SAME REAGENTS HAD UNUSUAL HIGHER RESULTS THAN THE EUROPEAN PARTICIPANTS. IT WAS NOT POSSIBLE TO DETERMINE WHETHER IT WAS RELATED TO REPORTING IN THE WRONG UNIT DUE TO A FEW TOSOH PARTICIPANTS FROM THESE GEOGRAPHICAL LOCATIONS. (B)(6) SENT THE SAMPLES TO THE TOSOH QUALITY ASSURANCE (QA) LAB FOR FURTHER TESTING. INVESTIGATION BY THE TOSOH QA LAB CORROBORATED WITH THE E2 RESULTS OBTAINED BY THE (B)(6) TESTING GROUP. THE RESULTS OBTAINED AT THE TOSOH QA LAB CONCLUDED THAT THESE MATCHED THE RESULTS OBTAINED IN CENTRAL AND LATIN AMERICA, WHICH MAY INDICATE THAT THE INITIAL PROBLEM OF THE LAB FOR URUGUAY WAS DUE TO REPORTING THE INCORRECT RESULTS AND NOT AN AIA-360 OR ANALYTE PERFORMANCE ISSUE. THERE IS NO EVIDENCE OF DISCREPANT E2 RESULTS FROM THIS INVESTIGATION. A 13-MONTH COMPLAINT AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WERE PERFORMED FOR SERIAL NUMBER (B)(6) FROM (B)(6) 2017 THROUGH (B)(6) 2019. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE MOST PROBABLE CAUSE WAS DUE TO INCORRECT E2 PATIENT RESULTS BEING REPORTED IN THE ONEWORLD ACCURACY TESTING PROGRAM BY THE CUSTOMER. 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.

    Additional Manufacturer Narrative · 0

    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. A 13 MONTH COMPLAINT AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WERE PERFORMED FOR TOSOH E2 ST AIA-PACK CATALOG NUMBER 025274 FROM 16DEC2017 THROUGH 16JAN2019. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE ESTRADIOL ST AIA-PACK PACKAGE INSERT STATES THE FOLLOWING: LIMITATIONS OF THE PROCEDURE FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD BE USED IN CONJUNCTION WITH OTHER DATA (E.G. SYMPTOMS, RESULTS OF OTHER TESTS, CLINICAL IMPRESSIONS, THERAPY, ETC.). EXPECTED VALUES EACH LABORATORY SHOULD DETERMINE A REFERENCE INTERVAL WHICH CORRESPONDS TO THE CHARACTERISTICS OF THE POPULATION BEING TESTED. AS WITH ALL DIAGNOSTIC PROCEDURES, CLINICAL RESULTS MUST BE INTERPRETED WITH REGARD TO CONCOMITANT MEDICATIONS ADMINISTERED TO THE PATIENT. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS STILL BEING INVESTIGATED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED TO THE DISTRIBUTOR IN (B)(4) SEEING HIGHER ESTRADIOL (E2) PATIENT RESULTS USING TOSOH ST AIA-PACK E2 TEST CUP, CATALOG NUMBER 025274, WITH THEIR AIA-360 ANALYZER. THE CUSTOMER REPORTED THAT E2 RESULTS HAVE BEEN CONSISTENTLY HIGHER WHEN COMPARED TO THE PEER GROUP; ABOUT THREE (3) TIMES HIGHER. THE CUSTOMER STATED THAT QUALITY CONTROLS (QC) WERE WITHIN ACCEPTABLE RANGES. THE CUSTOMER WAS ADVISED TO SEND THE SAMPLES TO THE TOSOH QUALITY ASSURANCE LAB FOR FURTHER EVALUATION. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133814 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1