BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 8220521 · Received January 5, 2019

    Report

    Report Number
    8031673-2018-05343
    Event Type
    Malfunction
    Date Received
    January 5, 2019
    Date of Event
    December 12, 2018
    Report Date
    May 8, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONAL DEVICE EVALUATION INFORMATION: H.3. DEVICE EVALUATION BY MANUFACTURER: THE FIELD SERVICE ENGINEER (FSE) CONTINUED TO PERFORM SERVICE ON THE INSTRUMENT. DURING SERVICING, FSE REPLACED THE SPECIMEN SYRINGE TO ENSURE PROPER SAMPLING. HOWEVER, THE PARATHYROID HORMONE (PTH) ISSUES CONTINUE TO OCCUR. FSE THEN SUSPECTED THAT THE DETECTOR WAS NOT READING LOW POINTS ON THE PTH. FSE REPLACED THE DETECTOR AND CALIBRATED THE DETECTOR. FSE ALSO CHECKED AND ADJUSTED THE DETECTOR TEMPERATURE ON THE NEW DETECTOR. FSE THEN CALIBRATED THE PTH ASSAY AND RAN QUALITY CONTROLS WITH ACCEPTABLE RESULTS. THE INSTRUMENT WAS OPERATING AS EXPECTED. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. THE SAMPLE SYRINGE PUMP AND THE DETECTOR UNIT WERE RETURNED FOR EVALUATION TO THE INSTRUMENT SERVICE CENTER. FUNCTIONAL TESTING WAS PERFORMED ON BOTH PARTS BY RUNNING PRECISION TESTS. WHILE TESTING THE SAMPLE SYRINGE PUMP, SEVERAL FAULTS OCCURRED AROUND THE CUP PICKUP ASSEMBLY LIKELY DUE TO ELECTRICAL OVERLOAD. THE PART FAILED TESTING BUT WAS NOT A CONTRIBUTING FACTOR TO THE REPORTED EVENT. THE DETECTOR PERFORMED AS EXPECTED AND ALL RESULTS OF THE PRECISION TEST WERE WITHIN RANGE. THE PART PASSED TESTING. THE REPORTED EVENT WAS NOT CONFIRMED. D10 DATE RETURNED TO MANUFACTURER: 22-JAN-2019. CORRECTED DATA: H6 EVALUATION CODES RESULTS: 213-NO DEVICE PROBLEM FOUND, CONCLUSION CODE: 67- NO PROBLEM DETECTED, 4315- CAUSE NOT ESTABLISHED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE DETECTOR PERFORMED AS EXPECTED.

    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) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING INSPECTION, FSE OBSERVED THAT THE RESULTS WERE OUT HIGH. FSE CLEANED THE SAMPLE NOZZLE. FSE THEN CHECKED THE LEVEL SENSING AND CLOG SENSING AND FOUND THE DETECTOR LENS DIRTY AND SPOTTY. FSE CLEANED DETECTOR LENS AND REPLACED THE BUSHINGS FOR THE WASH SYRINGE. HOWEVER, THE ISSUE CONTINUED. THE CUSTOMER RECEIVED NEW CALIBRATION OF THE SAME LOT, AND A NEW TEST CUP AND QUALITY CONTROL LOT. THE CUSTOMER PERFORMED AN EXTENSIVE DECONTAMINATION OF THE ANALYZER AND MADE FRESH WASH, DILUENT, AND SUBSTRATE. THE INSTRUMENT WAS OPERATING AS EXPECTED. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6) FROM 12-NOV-2017 THROUGH AWARE DATE (B)(6) 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. PARATHYROID HORMONE ST AIA-PACK PTH 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 INTACT PTH, THE HIGHEST CONCENTRATION OF INTACT PARATHYROID HORMONE MEASURABLE WITHOUT DILUTION IS APPROXIMATELY 2,000 PG/ML, AND THE LOWEST MEASURABLE CONCENTRATION IS 1.0 PG/ML (ASSAY SENSITIVITY). THE EXACT LINEARITY OF THE ST AIA-PACK INTACT PTH DEPENDS ON THE PARTICULAR LOT OF CALIBRATOR IN USE. ALTHOUGH THE APPROXIMATE VALUE OF THE HIGHEST CALIBRATOR IS 2,200 PG/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, 2000 PG/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 GOAT POLYCLONAL ANTIBODIES FOR DIAGNOSIS OR THERAPY MAY CONTAIN HUMAN ANTI-GOAT ANTIBODIES. SUCH SPECIMENS MAY SHOW FALSELY ELEVATED VALUES WHEN TESTED FOR INTACT PARATHYROID 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. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A DIRTY DETECTOR LENS AND THE INSTRUMENT NEEDED DECONTAMINATION.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THEY FAILED THE SECOND EVENT OF THE (B)(6) FOR PARATHYROID HORMONE (PTH) WITH AIA-900 INSTRUMENT. THE CUSTOMER REPORTED THAT ALL THREE RESULTS WERE OUT HIGH. THE QUALITY CONTROLS WERE RUNNING HIGH AS WELL. THE RESULTS OF THE SURVEY SAMPLES AND QUALITY CONTROLS WERE AS FOLLOWS: SURVEY SAMPLE RESULTS: SAMPLE 1: 160.2 PG/ML (112-148.3 PG/ML), SAMPLE 2: 128.2 PG/ML (97.4-112.6 PG/ML), SAMPLE 3: 72.2 PG/ML (49.4-64.7 PG/ML). QUALITY CONTROL (QC) RESULTS: LEVEL 1: 81 PG/ML, 64 PG/ML, 55 PG/ML (39.11-75.13 PG/ML), LEVEL 2: 814 PG/ML, 745 PG/ML, 859 PG/ML, 967 PG/ML (630-940 PG/ML). THE CUSTOMER RAN A 10 SAMPLE PRECISION TEST ON LEVEL 2 QC RESULTS AND ALL RESULTS WERE IN RANGE. THE RESULTS WERE AS FOLLOWS: LEVEL 2 QC PRECISION RESULTS: 909.6 PG/ML, 891.0 PG/ML, 869.2 PG/ML, 842.1 PG/ML, 823.2 PG/ML, 840.3 PG/ML, 820.2 PG/ML, 834.2 PG/ML, 828.2 PG/ML, 808.9 PG/ML. THE CUSTOMER WAS INSTRUCTED TO DO A BLEACH DECONTAMINATION OF THE INSTRUMENT, RECALIBRATE, AND THEN RUN ANOTHER PRECISION TEST. UPON FOLLOW UP, THE CUSTOMER REPORTED THE FOLLOWING PRECISION TEST RESULTS: LEVEL 2 QC PRECISION RESULTS (POST DECONTAMINATION): 836.1 PG/ML, 796.0 PG/ML, 793.0 PG/ML, 801.4 PG/ML, 775.0 PG/ML, 843.8 PG/ML, 779.6 PG/ML, 764.7 PG/ML, 752.2 PG/ML, 797.8 PG/ML. THE RESULTS OF THE LEVEL 2 QC PRECISION TESTING POST DECONTAMINATION WERE IN RANGE. A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER'S SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT PTH SURVEY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13227 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1