BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 8177358 · Received December 18, 2018

    Report

    Report Number
    8031673-2018-05340
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    November 26, 2018
    Report Date
    December 18, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. 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 26-OCT-2017 THROUGH AWARE DATE 26-NOV-2018. THERE WERE NO SIMILAR COMPLAINTS 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. SECTION 12 FLAGS AND ERROR MESSAGES STATES THE FOLLOWING: BF SEPARATION DID NOT TAKE PLACE CORRECTLY. PRINT AND DISPLAY (RATE VALUE) : OUTPUTS THE MEASUREMENT VALUES. PRINT AND DISPLAY (CONCENTRATION VALUE) : OUTPUTS THE MEASUREMENT RESULTS. HOWEVER, IF THE MEASUREMENT VALUE COINCIDES WITH NC, CL, CE, >H, OR <L, THE OUTPUT WILL BE BLANK. RS232C OUTPUT (CONCENTRATION VALUE) : OUTPUTS THE MEASUREMENT RESULTS. HOWEVER, IF THE MEASUREMENT VALUE COINCIDES WITH NC, CL, OR CE, THE OUTPUT WILL CONFORM TO THE SETTING IN THE CASE WHERE A CONCENTRATION VALUE IS NOT SET IN THE HOST. ALTERNATELY, IF THE MEASUREMENT VALUE COINCIDES WITH >H OR <L, THE OUTPUT CONFORMS TO THE SETTING THAT IS APPLICABLE TO THE CASE WHERE NO CALCULATION RESULT IS SET IN THE HOST. RS232C OUTPUT (FLAG) : A 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 DUE TO THE CUSTOMER USED CALIBRATION WITH WU FLAGS, WHICH CAUSED HIGH RESULTS.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THEY FAILED THE SECOND QUARTER AMERICAN PROFICIENCY INSTITUTE (API) SURVEY FOR CANCER ANTIGEN 125 (CA-125) ON THE AIA-900 INSTRUMENT. THE CUSTOMER STATED THAT THEY FAILED ONE SAMPLE OF THE FIRST QUARTER FOR CA-125 AND IN SECOND QUARTER, THEY FAILED TWO SAMPLES. THE CUSTOMER REPORTED THAT ALL SAMPLES THAT FAILED WERE OUT HIGH. THE BIO-RAD LOT 23960 QUALITY CONTROL VALUES WERE THE FOLLOWING: LEVEL 1 RANGE 40.8-75.8 U/ML, LEVEL 2 RANGE 87.2-161.9 U/ML, AND LEVEL 3 241.7-448.9 U/ML. THE PATIENT RESULTS WERE 54.7 U/ML, 155.2 U.ML, AND 429.2 U/ML WHICH WERE ALL IN RANGE BUT ON THE HIGH SIDE OF NORMAL. TECHNICAL SUPPORT (TS) HAD THE CUSTOMER RUN CALIBRATORS 1, 5, AND 6 AS PATIENTS TO CHECK RECOVERY. THE RECOVERY WAS HIGH ON THE CALIBRATORS AT 113.4%. THE CUSTOMER RECALIBRATED AND RAN QUALITY CONTROLS AND THEN SENT RESULTS OF THIS CALIBRATION AND A PREVIOUS CALIBRATION DONE ON (B)(6) 2018 TO TS. UPON REVIEW, THE RECALIBRATION WAS ACCEPTABLE BUT TS FOUND THAT THE (B)(6) 2018 CALIBRATION WAS USED TO RUN THE API SAMPLES. THE CALIBRATION FROM (B)(6) 2018 HAD WU FLAGS ON THE FIRST CALIBRATOR WITH ONE RESULT. THE CALIBRATION SHOULD NOT HAVE BEEN USED. THE QUALITY CONTROLS WERE RUNNING ON THE HIGH SIDE DUE TO THE WU FLAG. THE QUALITY CONTROLS FOR THE RECALIBRATION WERE AROUND THE MEAN AND WERE AS FOLLOWS: LEVEL 1-55.5 U/ML, LEVEL 2 123.7 U/ML, AND LEVEL 3 350.1 U/ML. THE CUSTOMER WAS UNABLE TO REPEAT THE API SAMPLES DUE TO IMPROPER STORAGE. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT CA- 125 SURVEY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016605 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1