BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7250278 · Received February 7, 2018

    Report

    Report Number
    8031673-2018-00031
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    January 8, 2018
    Report Date
    February 7, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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: ON 23-JAN-2018 A FIELD SERVICE ENGINEER (FSE) DECONTAMINATED THE SUBSTRATE SYSTEM, RAN 15% BLEACH SOLUTION, THEN DI WATER, AND RINSED WITH 70% ALCOHOL; THE CUSTOMER WAS USING 100% ALCOHOL. THE FSE INSTRUCTED THE CUSTOMER TO USE 70% ALCOHOL. THE FSE REPLACED THE SUBSTRATE SYRINGE AND PRIMED WITH 70% THE SUBSTRATE SOLUTION. THE FSE THEN PROCEEDED TO RUN QC, WHICH RECOVERED WITHIN ACCEPTABLE RANGE. THE AIA-900 WAS PERFORMING WITHIN SPECIFICATIONS; NO FURTHER ACTION REQUIRED. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS FOR THE AIA-900, SERIAL NUMBER (B)(4), WAS PERFORMED FROM 08-DEC-2016 THROUGH (B)(6) 2018. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE ST AIA-PACK PSA ASSAY APPLICATION MANUAL UNDER PAGE 10 STATES THE FOLLOWING: 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 DUE TO THE SUBSTRATE SYRINGE.

    Description of Event or Problem · 0

    ON (B)(6) 2018 A CUSTOMER REPORTED HIGHER THAN EXPECTED PROSTATE SPECIFIC ANTIGEN (PSA) PATIENT RESULTS WITH THE AIA-900 INSTRUMENT. THE PATIENT RESULTS WERE QUESTIONED BY THE ORDERING PHYSICIAN AND REPEATED. THE CUSTOMER REPORTED THAT QUALITY CONTROLS (QC) WERE WITHIN ACCEPTABLE RANGE. (B)(6). THE CUSTOMER REPORTED THAT THE AIA-900 INSTRUMENT WAS RECALIBRATED WITH THE SAME LOT OF CALIBRATORS AND PATIENT SAMPLES WERE REPEATED, WHICH OBTAINED LOWER RESULTS. QC VALUES WERE THE SAME. THE AIA-900 HAD THE SAME WASH SOLUTION, DILUENT SOLUTION, AND SUBSTRATE SOLUTION. THERE WAS NO INDICATION OF ANY IMPACT TO PATIENT MANAGEMENT OR ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91830 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1