BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 8263134 · Received January 19, 2019

    Report

    Report Number
    8031673-2019-00003
    Event Type
    Malfunction
    Date Received
    January 19, 2019
    Date of Event
    December 1, 2018
    Report Date
    January 19, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    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. H.3. DEVICE EVALUATION BY MANUFACTURER: A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6) FROM 08-DEC-2017 THROUGH AWARE DATE 08-JAN-2019. THERE WAS ONE (1) SIMILAR COMPLAINT FOUND DURING THE SEARCHED PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SAFETY PRECAUTIONS, STATES: OPERATE ONLY IN ACCORDANCE WITH THE PROCEDURES DESCRIBED IN THIS MANUAL - ATTEMPTS TO OPERATE THE AIA-900 USING PROCEDURES NOT PRESCRIBED IN THIS MANUAL MAY ADVERSELY AFFECT THE INTEGRITY OF ASSAY RESULTS AND CAUSE SYSTEM MALFUNCTIONS. UNDER SECTION 1 BASIC PRECAUTIONS: REAGENT HANDLING FOR REAGENTS REQUIRED LOT MANAGEMENT, THE AIA-900 RECOGNIZES THEIR LOT NUMBERS. SINCE MIXING SUCH REAGENTS FROM DIFFERENT LOTS MAKES THE LOT MANAGEMENT IMPOSSIBLE, REAGENTS MUST BE HANDLED CORRECTLY ACCORDING TO THEIR INSTRUCTIONS FOR USE. ST AIA-PACK PSA (PROSTATE ANTIGEN) ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: CALCULATION OF RESULTS THE AIA SYSTEMS PERFORM ALL SAMPLE AND REAGENT HANDLING OPERATIONS AUTOMATICALLY. ALL THE AIA SYSTEMS READ THE RATE OF FLUORESCENCE PRODUCED BY THE REACTION AND AUTOMATICALLY CONVERT THE RATE TO PROSTATE SPECIFIC ANTIGEN CONCENTRATION IN NG/ML. FOR SAMPLES REQUIRING DILUTION, THE AIA-900, AIA-600 II, AIA-1800 AND AIA-2000 WILL AUTOMATICALLY PERFORM DILUTIONS AND CALCULATE RESULTS IF THE DILUTION FACTORS ARE ENTERED INTO THE SOFTWARE. FOR DETAILED INFORMATION REGARDING PROGRAMMING DILUTIONS, CONSULT THE APPROPRIATE OPERATOR'S MANUAL. EVALUATION OF RESULTS QUALITY CONTROL IN ORDER TO MONITOR AND EVALUATE THE PRECISION OF THE ANALYTICAL PERFORMANCE, IT IS RECOMMENDED THAT COMMERCIALLY AVAILABLE CONTROL SAMPLES BE ASSAYED DAILY. THE MINIMUM RECOMMENDATIONS FOR THE FREQUENCY OF RUNNING INTERNAL CONTROL MATERIAL ARE: · AFTER CALIBRATION, THREE LEVELS OF CONTROLS ARE RUN IN ORDER TO ACCEPT THE CALIBRATION CURVE. · THE THREE LEVELS OF CONTROLS ARE ALSO REPEATED AFTER CALIBRATION WHEN CERTAIN SERVICE PROCEDURES ARE PERFORMED (E.G. TEMPERATURE ADJUSTMENT, SAMPLING MECHANISM CHANGES, MAINTENANCE OF THE WASH PROBE OR DETECTOR LAMP ADJUSTMENT OR CHANGE). · AFTER DAILY MAINTENANCE, AT LEAST TWO LEVELS OF THE CONTROL SHOULD BE RUN IN ORDER TO VERIFY THE OVERALL PERFORMANCE OF THE TOSOH AIA SYSTEM ANALYZERS. IF ONE OR MORE CONTROL SAMPLE VALUE(S) IS OUT OF THE ACCEPTABLE RANGE, IT WILL BE NECESSARY TO INVESTIGATE THE VALIDITY OF THE CALIBRATION CURVE BEFORE REPORTING PATIENT RESULTS. STANDARD LABORATORY PROCEDURES SHOULD BE FOLLOWED IN ACCORDANCE WITH THE REGULATORY AGENCY UNDER WHICH THE LABORATORY OPERATES. LIMITATIONS OF THE PROCEDURE 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). ALTHOUGH THE APPROXIMATE VALUE OF THE HIGHEST CALIBRATOR IS 50 NG/ML, THE EXACT CONCENTRATION MAY BE SLIGHTLY DIFFERENT. THE ASSAY SPECIFICATION, ASSAY RANGE HIGH, SHOULD BE DEFINED AS THE UPPER LIMIT OF THE ASSAY RANGE, 100 NG/ML. ALTHOUGH HEMOLYSIS HAS AN INSIGNIFICANT EFFECT ON THE ASSAY, HEMOLYZED SAMPLES MAY INDICATE MISTREATMENT OF A SPECIMEN PRIOR TO ASSAY AND RESULTS SHOULD BE INTERPRETED WITH CAUTION. LIPEMIA HAS AN INSIGNIFICANT EFFECT ON THE ASSAY EXCEPT IN THE CASE OF GROSS LIPEMIA WHERE SPATIAL INTERFERENCE MAY OCCUR. SPECIMENS FROM PATIENTS WHO HAVE RECEIVED PREPARATIONS OF MOUSE MONOCLONAL ANTIBODIES FOR DIAGNOSIS OR THERAPY MAY CONTAIN HUMAN ANTI-MOUSE ANTIBODIES (HAMA). SUCH SPECIMENS MAY SHOW FALSELY ELEVATED OR DECREASED PSA VALUES. CERTAIN MEDICATIONS MAY INTERFERE WITH ASSAY PERFORMANCE. ALL RESULTS SHOULD BE INTERPRETED WITH RESPECT TO THE CLINICAL PICTURE OF THE PATIENT. FOR A MORE COMPLETE UNDERSTANDING OF THE LIMITATIONS OF THIS PROCEDURE, PLEASE REFER TO THE SPECIMEN COLLECTION AND HANDLING, WARNINGS AND PRECAUTIONS, STORAGE AND STABILITY, AND PROCEDURAL NOTES SECTIONS IN THIS INSERT SHEET. 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. 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. ST AIA-PACK CA 125 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.). USING ST AIA-PACK CA 125, THE HIGHEST CONCENTRATION OF CA 125 MEASURABLE WITHOUT DILUTION IS 1000 U/ML, AND THE LOWEST MEASURABLE CONCENTRATION IS 2.0 U/ML (ASSAY SENSITIVITY). ALTHOUGH THE APPROXIMATE VALUE OF THE HIGHEST CALIBRATOR IS 1000 U/ML, THE EXACT CONCENTRATION MAY BE SLIGHTLY DIFFERENT. THE ASSAY SPECIFICATION, ASSAY RANGE HIGH, SHOULD BE DEFINED AS THE UPPER LIMIT OF THE ASSAY RANGE, 1000 U/ML. ALTHOUGH HEMOLYSIS HAS AN INSIGNIFICANT EFFECT ON THE ASSAY, HEMOLYZED SAMPLES MAY INDICATE MISTREATMENT OF A SPECIMEN PRIOR TO ASSAY AND RESULTS SHOULD BE INTERPRETED WITH CAUTION. LIPEMIA HAS AN INSIGNIFICANT EFFECT ON THE ASSAY EXCEPT IN THE CASE OF GROSS LIPEMIA WHERE SPATIAL INTERFERENCE MAY OCCUR. SPECIMENS FROM PATIENTS WHO HAVE RECEIVED PREPARATIONS OF MOUSE MONOCLONAL ANTIBODIES FOR DIAGNOSIS OR THERAPY MAY CONTAIN HUMAN ANTI-MOUSE ANTIBODIES (HAMA). SUCH SPECIMENS MAY SHOW FALSELY ELEVATED VALUES WHEN TESTED FOR CA 125. A CA 125 RESULT BELOW 35 U/ML DOES NOT INDICATE THE ABSENCE OF RESIDUAL OVARIAN CANCER BECAUSE PATIENTS WITH HISTOPATHOLOGIC EVIDENCE OF OVARIAN CARCINOMA MAY HAVE CA 125 ASSAY VALUES WITHIN THE RANGE OF NORMAL INDIVIDUALS. CONVERSELY, A CA 125 ASSAY VALUE EXCEEDING 35 U/ML DOES NOT NECESSARILY INDICATE THE PRESENCE OF OVARIAN MALIGNANCY SINCE 1-2% OF HEALTHY INDIVIDUALS AND INDIVIDUALS WITH NON-MALIGNANT CONDITIONS MAY HAVE ELEVATIONS IN CA 125 ASSAY RESULTS. A CA 125 ASSAY VALUE SHOULD NOT BE INTERPRETED AS ABSOLUTE EVIDENCE FOR THE PRESENCE OR ABSENCE OF MALIGNANT DISEASE. THE ST AIA-PACK CA 125 ASSAY SHOULD NOT BE USED AS A SCREENING TEST. CERTAIN MEDICATIONS MAY INTERFERE WITH ASSAY PERFORMANCE. ALL RESULTS SHOULD BE INTERPRETED WITH RESPECT TO THE CLINICAL PICTURE OF THE PATIENT. 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 WAS THE INSTRUMENT WAS CONTAMINATED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THEY HAD REPORTED OUT A DISCREPANT PROSTATE ANTIGEN (PSA) RESULT IN (B)(6) 2018 ON THE AIA-900 INSTRUMENT. THE PSA RESULT WAS 17.25 NG/ML. PRIOR MONITORING OF THE PATIENT REVEALED AN INITIAL PSA RESULT OF LESS THAN 0.05 NG/ML WITH A REDRAW OF ALSO LESS THAN 0.05 NG/ML. THEN IN (B)(6) 2018, THE CUSTOMER REPORTED OUT A DISCREPANT CANCER ANTIGEN 125 (CA-125) RESULT ON A DIFFERENT PATIENT. THE CA-125 RESULT WAS 200 U/ML. PRIOR MONITORING OF THE PATIENT REVEALED AN INITIAL CA-125 RESULT OF LESS THAN 2 U/ML WITH A REDRAW OF ALSO LESS THAN 2 U/ML (REFER TO MFR REPORT #: 8031673-2019-00002 / UF/IMPORTER REPORT #: (B)(4)). THE QUALITY CONTROLS THAT WERE RUN ON THE DAY THE ERRONEOUS RESULTS OCCURRED WERE IN RANGE AND OTHER PATIENT SAMPLES IN THE SAME RUN HAD EXPECTED RESULTS. THERE WERE NO SAMPLES AVAILABLE TO RERUN. THE SAMPLE RESULTS WERE REPORTED OUT TO THE PHYSICIAN WHO RECOGNIZED THAT THE RESULTS DID NOT FIT THE CLINICAL PICTURE OF THE PATIENTS AND THEREFORE NO TREATMENT WAS AFFECTED. TECHNICAL SUPPORT FOLLOWED UP WITH THE CUSTOMER AND ADVISED THAT THE ISSUE WAS LIKELY AS A RESULT OF CONTAMINATION AND TO PERFORM A DECONTAMINATION OF THE INSTRUMENT. THERE WERE NO FURTHER ISSUES REPORTED SINCE THE SECOND OCCURRENCE OF DISCREPANT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT PROSTATE ANTIGEN (PSA) AND CANCER ANTIGEN 125 (CA-125) PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55866 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1