BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 8031379 · Received November 1, 2018

    Report

    Report Number
    8031673-2018-00988
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    August 20, 2018
    Report Date
    November 1, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A 13-MONTH COMPLAINT AND SERVICE HISTORY REVIEW WAS CONDUCTED FOR CALIBRATOR SET LOT NUMBER HZ231224 AND PSA ASSAY PACK LOT NUMBER I212886 FOR SIMILAR COMPLAINTS. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE PROSTATE SPECIFIC ANTIGEN ST AIA-PACK PA 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.). USING ST AIA-PACK PA, THE HIGHEST CONCENTRATION OF PROSTATE SPECIFIC ANTIGEN MEASURABLE WITHOUT DILUTION IS 100 NG/ML, AND THE LOWEST MEASURABLE CONCENTRATION IS 0.05 NG/ML (ASSAY SENSITIVITY). 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 PROBABLE CAUSE OF THE REPORTED COULD NOT BE DETERMINED; THE ISSUE WAS RESOLVED BY RECALIBRATING THE AIA-2000 ANALYZER WITH A NEW LOT OF CALIBRATORS. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED IMPRECISION ON PROSTATE SPECIFIC ANTIGEN (PSA) PATIENT SAMPLES AT THE LOW END SENSITIVITY OF THE CALIBRATION CURVE WITH THE AIA-2000 ANALYZER. THE CUSTOMER PROVIDED A PATIENT SAMPLE, AS PART OF TROUBLESHOOTING, WITH PSA RESULTS OF 0.07 NG/ML, 0.07 NG/ML, 0.07 NG/ML, 0.06 NG/ML, 0.07 NG/ML, 11.0 NG/ML, 11.0 NG/ML, 0.06 NG/ML, AND <0.05 NG/ML (ASSAY SENSITIVE = 0.05 NG/ML AND ASSAY RANGE = TO 100 NG/ML), RESPECTIVELY. THE CUSTOMER COULD NOT CONFIRM WHEN THE ISSUE BEGAN, BUT REPORTED USING CALIBRATION SET LOT # HZ231224 AND PSA ASSAY PACK LOT # I212886 SINCE (B)(6) 2018 AND BELIEVED THE ISSUE MAY HAVE BEGUN AFTER THIS TIME FRAME. THE CUSTOMER WAS TO RE-CALIBRATE WITH A NEWER LOT OF CALIBRATORS AND WAS TO RUN AGAIN A LOW SENSITIVITY PATIENT FOR IMPRECISION. THE TECHNICAL SUPPORT SPECIALIST FOLLOWED-UP WITH THE CUSTOMER AT A LATER DATE AND CONFIRMED THAT AFTER CALIBRATING THE AIA-2000 ANALYZER WITH THE NEWER LOT OF CALIBRATORS THERE HAVE BEEN NO FURTHER OCCURRENCES OF PSA IMPRECISION ON THE LOW END SENSITIVITY OF THE PSA RANGE. THERE IS NO INDICATION OF ANY ADVERSE HEALTH CONSEQUENCES OR MEDICAL INTERVENTION DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868796 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1