BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 8144625 · Received December 7, 2018

    Report

    Report Number
    8031673-2018-05293
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    November 12, 2018
    Report Date
    December 7, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED ISSUE. FSE CONFIRMED CUSTOMER'S COMPLAINT. FSE CLEANED BF PROBE AND SAMPLE DRAIN, CHECKED TUBING TO WASTE PUMP AND ALL FITTINGS AND CONNECTORS. FSE VERIFIED PROPER OPERATION WITHOUT ANY ERRORS. FSE RAN PATIENT SAMPLES, PROFICIENCY TESTING, PRECISION AND QUALITY CONTROL (QC). ALL RESULTS PASSED WITHOUT ERRORS. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-360 INSTRUMENT IS FUNCTIONING AS EXPECTED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4). THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE ST AIA-PACK PROGESTERONE (PROG) ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: SPECIMEN COLLECTION AND HANDLING SERUM OR HEPARINIZED PLASMA IS REQUIRED FOR THE ASSAY. EDTA AND CITRATED PLASMA SHOULD NOT BE USED. NO SPECIAL PATIENT PREPARATION IS NECESSARY. WHEN USING SERUM, A VENOUS BLOOD SAMPLE IS COLLECTED ASEPTICALLY WITHOUT ADDITIVES (RED TOP TUBE). STORE AT 18-25°C UNTIL A CLOT HAS FORMED (USUALLY 15 - 45 MINUTES), THEN CENTRIFUGE TO OBTAIN THE SERUM SPECIMEN FOR ASSAY. SST OR GEL TUBES HAVE NOT BEEN VALIDATED. TO USE HEPARINIZED PLASMA, A VENOUS BLOOD SAMPLE IS COLLECTED ASEPTICALLY WITH THE DESIGNATED ADDITIVE. CENTRIFUGE AND SEPARATE PLASMA FROM THE PACKED CELLS AS SOON AS POSSIBLE. SAMPLES MAY BE STORED AT 2° - 8° C FOR UP TO 24 HOURS PRIOR TO ANALYSIS. IF THE ANALYSIS CANNOT BE DONE WITHIN 24 HOURS, THE SAMPLE SHOULD BE STORED FROZEN AT -20° C OR BELOW FOR UP TO 60 DAYS. REPEATED FREEZE-THAW CYCLES SHOULD BE AVOIDED. TURBID SERUM SAMPLES OR SAMPLES CONTAINING PARTICULATE MATTER SHOULD BE CENTRIFUGED PRIOR TO TESTING. PRIOR TO ASSAY, SLOWLY BRING FROZEN SAMPLES TO ROOM TEMPERATURE (18° - 25° C) AND MIX GENTLY. THE SAMPLE REQUIRED FOR ANALYSIS IS 75UL. 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 PROG, THE HIGHEST CONCENTRATION OF PROGESTERONE MEASURABLE WITHOUT DILUTION IS APPROXIMATELY 40 NG/ML, AND THE LOWEST MEASURABLE CONCENTRATION IS 0.1 NG/ML (ASSAY SENSITIVITY). ALTHOUGH THE APPROXIMATE VALUE OF THE HIGHEST CALIBRATOR IS 45 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, 40 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. 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. THE AIA-360 OPERATOR'S MANUAL UNDER CHAPTER 10: DAILY MAINTENANCE PROCEDURE PROVIDES DETAILED MAINTENANCE INFORMATION. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO CLOGGED BF PROBE.

    Description of Event or Problem · 0

    TOSOH BECAME AWARE THAT DURING A PROFICIENCY TESTING PERFORMANCE WITH SURVEY SAMPLES, THE CUSTOMER FAILED 2 OUT OF 3 OF THE PROGESTERONE III (PROG III) ANALYTES ON THE AIA-360 INSTRUMENT. THE PROGESTERONE RESULTS WERE OUT OF RANGE ON THE LAST SET OF SURVEY SAMPLES. THE CUSTOMER PROVIDED (B)(6) SURVEY SAMPLE RESULTS AS FOLLOW: (B)(6). TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO RUN ONE SAMPLE EIGHT TIMES TO CHECK PRECISION. CUSTOMER RAN ONE SAMPLE 8 TIMES AS INSTRUCTED BUT FAILED PRECISION. THE CUSTOMER CONFIRMED THAT BIO-RAD QUALITY CONTROLS(QC) RUN WERE WITHIN ACCEPTABLE RANGES AND ALL MAINTENANCE HAS BEEN DONE ACCORDING TO SCHEDULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981448 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1