BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-600II

    MDR report key: 7311706 · Received March 2, 2018

    Report

    Report Number
    8031673-2018-00140
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    January 30, 2018
    Report Date
    December 18, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. DEVICE EVALUATION BY MANUFACTURER: NO CONCLUSION IS YET AVAILABLE; INVESTIGATION IS CURRENTLY IN-PROCESS.

    Additional Manufacturer Narrative · 0

    H.10. ADDITIONAL MANUFACTURER NARRATIVE: A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE PROSTATE SPECIFIC ANTIGEN ST AIA-PACK PA ANALYTE APPLICATION MANUAL 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 CORRESPONDING 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. RESULTS FROM THE ST AIA-PACK PA ASSAY SHOULD NOT BE INTERPRETED AS BEING DEFINITIVE FOR THE PRESENCE OR ABSENCE OF PROSTATE CANCER. PATIENTS WITH LEVELS OF PSA WITHIN THE REFERENCE INTERVAL FOUND IN APPARENTLY HEALTHY SUBJECTS MAY HAVE PROSTATE CANCER; PATIENTS WITH LEVELS EXCEEDING THOSE IN THE REFERENCE INTERVAL MAY BE PROSTATE CANCER FREE. RESULTS FROM THE ST AIA-PACK PA SHOULD BE INTERPRETED IN THE LIGHT OF OTHER CLINICAL FINDINGS AND DIAGNOSTIC PROCEDURES SUCH AS DRE. BIOPSY OF THE PROSTATE IS CURRENTLY THE MEDICALLY ACCEPTED STANDARD USED TO CONFIRM THE PRESENCE/ABSENCE OF PROSTATE CANCER. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS POSSIBLY DUE TO A FIBRIN STRAND INTERFERING WITH THE SUBJECT SAMPLE, WHICH CAUSED AN INITIAL <.0.05 PSA RESULT. H.11 CORRECTED DATA: FOR CORRECTED DATA REFER TO SECTION B.5 DESCRIBE EVENT OR PROBLEM. 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

    (B)(4), PER EXEMPTION NUMBER E2017013. EVENT DATE: DATE OF EVENT IN THE INITIAL MDR SUBMISSION SHOULD HAVE BEEN (B)(6) 2018.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED A PROSTATE SPECIFIC ANTIGEN (PSA) PATIENT RESULT, RAN ON (B)(6) 2018, OBTAINED A RESULT OF <0.05 NG/ML (REFERENCE RANGE 0 - 4.0 NG/ML) ON THE AIA-600II ANALYZER, WHICH WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT SAMPLE WAS REPEATED ON (B)(6) 2018 WITH A PSA RESULT OF 3.44 NG/ML. THE CUSTOMER REPORTED THAT THERE WAS NO CHANGE IN PATIENT TREATMENT AS A RESULT OF THE FIRST PSA RESULT. THE TECHNICAL SUPPORT SPECIALIST (PSA) INSTRUCTED THE CUSTOMER TO REPEAT THE SUBJECT SAMPLE AND RUN A PRECISION TEST ON PSA. ON (B)(6) 2018, THE CUSTOMER REPORTED THAT REPEATED PSA RUN ON THE SUBJECT SAMPLE OBTAINED A 3.46 NG/ML RESULT. PRECISION WAS RUN ON ONE (1) PATIENT SAMPLE AND WAS WITHIN RANGE. THE CUSTOMER REPORTED THAT THE SUBJECT SAMPLE HAD ALSO BEEN RUN ON VITAMIN D AND THYROID STIMULATING HORMONE (TSH) ON (B)(6) 2018. THE TSS SUGGESTED TO THE CUSTOMER TO REPEAT THOSE TWO (2) AS WELL. THE CUSTOMER REPORTED THAT REPEATED RUNS FOR TSH AND VITAMIN D WERE THE SAME AS THE INITIAL RESULTS OF (B)(6) 2018.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED A PROSTATE SPECIFIC ANTIGEN (PSA) PATIENT RESULT, RAN ON (B)(6) 2018, OBTAINED A RESULT OF <0.05 NG/ML (REFERENCE RANGE 0 - 4.0 NG/ML) ON THE AIA-600II ANALYZER, WHICH WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT SAMPLE WAS REPEATED ON (B)(6) 2018 WITH A PSA RESULT OF 3.44 NG/ML. THE CUSTOMER REPORTED THAT THERE WAS NO CHANGE IN PATIENT TREATMENT AS A RESULT OF THE FIRST PSA RESULT. THE TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO REPEAT THE SUBJECT SAMPLE AND RUN A PRECISION TEST ON PSA. ON (B)(6) 2018, THE CUSTOMER REPORTED THAT REPEATED PSA RUN ON THE SUBJECT SAMPLE OBTAINED A 3.46 NG/ML RESULT. PRECISION WAS RUN ON ONE (1) PATIENT SAMPLE AND WAS WITHIN RANGE. THE ORIGINAL SAMPLE WAS RAN ON TSH AND FT4 AS WELL. THE TSS ADVISED THE CUSTOMER TO REPEAT THOSE TWO TESTS AS WELL, WHICH CONFIRMED TO MATCH THE ORIGINAL RESULTS. THERE IS NO INDICATION OF ANY ADVERSE HEALTH CONSEQUENCES OR IMPACT TO PATIENT MANAGEMENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152676 AIA-600II AIA-600II KHO TOSOH CORPORATION AIA-600II

    Patients

    Seq Age Sex Outcome Treatment
    1