BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA 900

    MDR report key: 10581599 · Received September 24, 2020

    Report

    Report Number
    3005529799-2020-00049
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    September 3, 2020
    Report Date
    September 24, 2020
    Manufacturer
    TOSOH BIOSCIENCE, INC.
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. DEVICE EVALUATION BY MANUFACTURER: A FIELD SERVICE ENGINEERING (FSE) WAS AT THE CUSTOMER'S SITE TO ADDRESS REPORTED EVENT. FSE CONFIRMED THE VARYING RESULTS BY REVIEWING THE INSTRUMENT PRINTOUT BUT WAS UNABLE TO REPRODUCE THE BHCG VARYING RESULTS DUE TO ITS INTERMITTENT OCCURRENCE. FSE PROACTIVELY REPLACED THE SAMPLE NOZZLE AND SAMPLE SYRINGE AND PERFORMED ALL THE ALIGNMENTS FOR THE SAMPLE NOZZLE POSITION AND ALSO REPLACED THE WASH SYRINGE AND 3-WAY SUBSTRATE VALVE SINCE THE ISSUE WAS INTERMITTENT. THE AIA-900 INSTRUMENT IS FUNCTIONING AS EXPECTED. NO FURTHER ACTION REQUIRED BY FSE. A 13-MONTH COMPLAINT HISTORY REVIEW, AND SERVICE HISTORY REVIEW THROUGH AWARE DATE OF EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4). THERE WERE TWO (2) SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD, WHICH INCLUDES THIS EVENT. THE ST AIA-PACK BHCG 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 BHCG, THE HIGHEST CONCENTRATION OF TOTAL BETA HCG MEASURABLE WITHOUT DILUTION IS 400 MIU/ML, AND THE LOWEST MEASURABLE CONCENTRATION IS 0.5 MIU/ML (ASSAY SENSITIVITY). ALTHOUGH THE APPROXIMATE VALUE OF THE HIGHEST CALIBRATOR IS 200 MIU/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, 400 MIU/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. 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 OF THE REPORTED EVENT IS UNKNOWN, POSSIBLY FAULTY SAMPLE NOZZLE & SAMPLE SYRINGE & WASH SYRINGE & 3-WAY SUBSTRATE VALVE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GETTING ERRATIC RESULTS FOR BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) SAMPLE RUNS WITH THE AIA-900 INSTRUMENT. THE CUSTOMER STATED, SOMETIMES RESULTS ARE OUT OF RANGE LOW, AND WHEN RERUN RESULTS BECOME OUT OF RANGE HIGH. CUSTOMER ALSO STATED RESULTS ARE INCONSISTENT WHEN DILUTIONS ARE RUN. CUSTOMER CONFIRMED INSTRUMENT FLUIDS WERE SUFFICIENT AND QUALITY CONTROL WAS IN RANGE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF BHCG PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048255 AIA 900 AIA 900 KHO TOSOH BIOSCIENCE, INC. AIA 900

    Patients

    Seq Age Sex Outcome Treatment
    1