BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 19430778 · Received May 30, 2024

    Report

    Report Number
    3004529019-2024-00564
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 7, 2024
    Report Date
    May 30, 2024
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED ISSUE BY REVIEW OF THE ERROR LOG. DURING REVIEW OF THE ERROR LOG, THE FSE IDENTIFIED THAT ERROR 3131 MAIN F1 +5V FUSE BLEW OCCURRED FIRST RESULTING IN THE REPORTED ERROR 4123. THE FSE CHECKED FUSE F1 ON THE MAIN BOARD, AND REPLACED THE F1 FUSE, WHICH RESOLVED THE ERRORS. BASED ON CUSTOMER'S REPORTED POTENTIAL DISCREPANT RESULTS FOR THYROID STIMULATING HORMONE (TSH), FSE ALSO INSPECTED THE SAMPLE NOZZLE AND FOUND DRIED SERUM IN THE SAMPLE NOZZLE CREATING A PARTIAL OBSTRUCTION. THE FSE CLEANED THE SAMPLE NOZZLE TO REMOVE THE OBSTRUCTION AND RAN PRECISION WITH NO ISSUES AND NO RECURRING ERRORS. THE AIA-900 ANALYZER IS FUNCTIONING AS EXPECTED. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW THROUGH AWARE DATE OF EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6). THERE WERE NO OTHER SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 12: FLAGS AND ERROR MESSAGES STATES THE FOLLOWING: [3131] MAIN F1 +5V FUSE BLEW CAUSE: BLOWN +5 V FUSE OF MAIN F1 WAS DETECTED. SAMPLING WILL BE INTERRUPTED. ACTION: PLEASE CONTACT TOSOH LOCAL REPRESENTATIVES. CHECK THE MAIN F1 FUSE. THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 12: FLAGS AND ERROR MESSAGES STATES THE FOLLOWING: [4123] SAMPLE-Z HOME OVERRUN CAUSE: THE HOME SENSOR (B)(6) , WHICH IS NOT SUPPOSED TO BE ACTIVATED AFTER THE SPECIMEN DISPENSING ARM Z MOVES, WAS ACTIVATED. A RETRY WILL TAKE PLACE, AND IF THERE IS NO IMPROVEMENT A MF FLAG WILL BE ATTACHED TO THE MEASUREMENT RESULT. ACTION: PLEASE CONTACT TOSOH LOCAL REPRESENTATIVES. CHECK (B)(6) AND ALSO CHECK TO SEE THE CAUSE OF SLIPPING, AND SO ON, THAT OCCURS WHEN PM051 MOVES TO THE LIMIT SIDE. THE ST TSH 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 TSH, THE HIGHEST CONCENTRATION OF THYROID STIMULATING HORMONE MEASURABLE WITHOUT DILUTION IS APPROXIMATELY 100 IU/ML, AND THE LOWEST MEASURABLE CONCENTRATION IS 0.03 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. SPECIMENS FROM PATIENTS TAKING MEDICINES AND/OR MEDICAL TREATMENT MAY SHOW ERRONEOUS RESULTS. 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. THE MOST PROBABLE CAUSE WAS DUE TO A BLOWN FUSE, COMPONENT FAILURE, AND BIOLOGICAL CONTAMINATION OF THE SAMPLE NOZZLE, USER ERROR.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED 4123 (900 ONLY) SAMPLE-Z HOME OVERRUN ON THE AIA-900 ANALYZER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. WHILE FSE WAS TROUBLESHOOTING, THE CUSTOMER REPORTED POTENTIAL DISCREPANT RESULTS FOR THYROID STIMULATING HORMONE (TSH). THE CUSTOMER STATED ONE PATIENT SAMPLE WAS REPORTED OUT TO THE PHYSICIAN AND THE PHYSICIAN QUESTIONED THE RESULT. A NEW PATIENT SAMPLE WAS REDRAWN AND RETESTED AT A REFERENCE LAB. THE PATIENT WAS NOT TREATED BASED ON THE INITIAL QUESTIONABLE RESULT. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT PATIENT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099348 AIA-900 FLUOROMETER, FOR CLINICAL USE KHO TOSOH HI-TEC, INC. AIA-900 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown