BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7239281 · Received February 2, 2018

    Report

    Report Number
    8031673-2018-00027
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    January 5, 2018
    Report Date
    January 5, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: 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

    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. DEVICE EVALUATION BY MANUFACTURER: THE ANALYZER WAS DEINSTALLED AND RETURNED TO THE INSTRUMENT SERVICE CENTER (ISC) FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED BY RUNNING A 10-SAMPLE PRECISION TEST USING MAC QUALITY CONTROLS IN AN EFFORT TO REPLICATE THE OUT-OF-RANGE RESULTS. THE PRECISION TEST RESULTS WERE OUT OF RANGE FOR ONE SAMPLE AND NO FURTHER TESTING WAS PERFORMED AT THAT TIME. THE ISSUE WAS CONFIRMED. THE ISC TECHNICIAN THEN PERFORMED DECONTAMINATION ON THE INSTRUMENT TO TROUBLESHOOT THE ISSUE. PRECISION TESTING WAS PERFORMED AGAIN AND ALL PRECISION TEST SAMPLE RESULTS WERE IN RANGE. THE INSTRUMENT PASSED TESTING. EVALUATION CODES: METHOD: 4109 HISTORICAL DATA ANALYSIS; 10 TESTING ON ACTUAL/SUSPECTED DEVICE; RESULTS: 142 BIOLOGICAL CONTAMINATION; CONCLUSION CODE: 51 CAUSE TRACED TO MAINTENANCE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS INSTRUMENT CONTAMINATION. ADDITIONAL INFORMATION: THE AIA-PACK THYROID STIMULATING HORMONE (TSH) ANALYTE APPLICATION MANUAL (AAM) STATES THE FOLLOWING: 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: 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 AIA-PACK TSH 3RD-GEN, THE HIGHEST CONCENTRATION OF THYROID STIMULATING HORMONE MEASURABLE WITHOUT DILUTION IS APPROXIMATELY 100 IU/ML, AND THE LOWEST MEASURABLE CONCENTRATION IS 0.01 IU/ML (ASSAY SENSITIVITY). ALTHOUGH THE APPROXIMATE VALUE OF THE HIGHEST CALIBRATOR IS 100 IU/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 IU/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 THYROID STIMULATING HORMONE. 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.12 REFERENCE RANGES: THE INTERVAL GIVEN HERE WAS DETERMINED IN SERUM SAMPLES FROM 127 APPARENTLY HEALTHY INDIVIDUALS. THE SAMPLES WERE TESTED FOR TGAB AND TPOAB IN ADDITION TO TSH. REFERENCE INTERVAL (INCLUDING ALL 127 SPECIMENS) = 0.5 - 5.8 [?]IU/ML. REFERENCE INTERVAL (107 SPECIMENS AFTER EXCLUDING SAMPLES WITH HIGH TGAB AND TPOAB) = 0.6 - 4.8 [?]IU/ML. THE AIA-900 OPERATOR'S MANUAL UNDER SAFETY PRECAUTIONS STATE THE FOLLOWING: WARNING: CONTACT A TOSOH LOCAL REPRESENTATIVE. THERE IS ALWAYS THE POSSIBILITY THAT BLOOD AND BODY FLUID MAY HAVE BEEN CONTAMINATED BY INFECTIOUS AGENTS. MISTAKES IN SYSTEM REPAIR OR DISPOSAL CAN RESULT IN THE TRANSMISSION OF INFECTIOUS AGENTS TO THE SYSTEM OPERATOR AND/OR TO NEARBY PERSON. PLEASE CONTACT A TOSOH LOCAL REPRESENTATIVE FOR ANALYZER REPAIRS OR INFORMATION ON DISPOSAL.

    Description of Event or Problem · 0

    ON (B)(6) 2018 A CUSTOMER REPORTED THAT A THYROID STIMULATING HORMONE (TSH) PATIENT RESULT OF 8.97 ULU/ML, WHICH WAS RUN ON (B)(6) 2018, WAS QUESTIONED BY A PHYSICIAN AS BEING LOWER THAN EXPECTED FOR THIS SPECIFIC PATIENT ON THE AIA-900 INSTRUMENT. THE PATIENT SAMPLE WAS REPEATED ON (B)(6) 2018 AND THE RESULT WAS 5.93 ULU/ML. THE PATIENT SAMPLE WAS SENT OUT FOR CONFIRMATION TO LABCORP WITH A RESULT OF 4.78 ULU/ML. THE CUSTOMER REPORTED THAT QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGE ON BOTH DAYS THE PATIENT SAMPLE WAS RUN. THERE IS NO INDICATION OF ANY ADVERSE HEALTH CONSEQUENCES OR CHANGE IN PATIENT TREATMENT AS A RESULT OF THIS DISCREPANT TSH RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79996 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1