BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7840313 · Received August 31, 2018

    Report

    Report Number
    8031673-2018-00810
    Event Type
    Malfunction
    Date Received
    August 31, 2018
    Date of Event
    June 20, 2018
    Report Date
    August 31, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION BY MANUFACTURER: FIVE (5) E2 SAMPLES WERE PROVIDED BY THE CUSTOMER TO BE RUN WITH AN AIA-900 INSTRUMENT, SERIAL NUMBER (B)(4) AT THE TOSOH QA LAB. PRIOR TO RUNNING THE FIVE (5) E2 PATIENT SAMPLES, THE AIA-900 WAS CALIBRATED WITHOUT ANY ISSUES. BIO-RAD QUALITY CONTROLS WERE RUN AND RECOVERED WITHIN EXPECTED RESULTS. TWO (2) E2 SAMPLES, PATIENT 1 AND PATIENT 3, WERE DETERMINED TO BE DISCREPANT RESULTS WHEN COMPARED TO THOSE PROVIDED BY THE CUSTOMER. PATIENT NO: PATIENT 1, QA LAB RESULT: 86.3 PG/ML, CUSTOMER RESULT: 103.2L PG/ML; PATIENT NO: PATIENT 2, QA LAB RESULT: *5880.3 PG/ML, CUSTOMER RESULT: >3000 PG/ML; PATIENT NO: PATIENT 3, QA LAB RESULT: 38.5 PG/ML, CUSTOMER RESULT: 52.60 PG/ML**; PATIENT NO: PATIENT 4, QA LAB RESULT: 74.9 PG/ML, CUSTOMER RESULT: 82.50 PG/ML; PATIENT NO: PATIENT 5, QA LAB RESULT: 78.9 PG/ML, CUSTOMER RESULT: 77.90 PG/ML. * RESULT OBTAINED BY AUTOMATED DILUTION 1:5 WITH THE AIA-900 INSTRUMENT. ** REFER TO (B)(6). THE E2 RESULTS FOR PATIENT 4 AND PATIENT 5 WERE WITHIN THE (B)(4)% COEFFICIENT OF VARIATION (CV%) AS STATED IN THE ESTRADIOL ST AIA-PACK E2 ANALYTE APPLICATION MANUAL. IT IS NOT KNOWN WHETHER THE RESULT FOR PATIENT 2 WAS DILUTED BY THE CUSTOMER. THE AIA-900, SERIAL NUMBER (B)(4), WAS INSTALLED AT THE ACCOUNT ON (B)(6) 2017; COMPLAINT AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FROM (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE ESTRADIOL ST AIA-PACK E2 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 E2, THE HIGHEST CONCENTRATION OF ESTRADIOL MEASURABLE WITHOUT DILUTION IS APPROXIMATELY 3000 PG/ML, AND THE LOWEST MEASURABLE CONCENTRATION IS 25 PG/ML (ASSAY SENSITIVITY). ALTHOUGH THE APPROXIMATE VALUE OF THE HIGHEST CALIBRATOR IS 3250 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, 3000 PG/ML. 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 AIA-900 OPERATOR'S MANUAL UNDER SECTION 11, MAINTENANCE, PROVIDES SPECIFIC INSTRUCTIONS FOR MONTHLY AND ONE EVERY THREE (3) MONTHS MAINTENANCE TO BE PERFORMED ON THE AIA-900 INSTRUMENT. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO CONTAMINATION OF THE REAGENT LINES, AS INDICATED BY THE INFORMATION PROVIDED BY THE CUSTOMER. THE CUSTOMER CONFIRMED THAT AFTER PERFORMING THE QUARTERLY DECONTAMINATION PROCEDURE ON THE AIA-900 INSTRUMENT NO E2 PATIENT RESULTS WITH <25 PG/ML WERE SEEN. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED ESTRADIOL (E2) PATIENT SAMPLES WITH <25 PG/ML RESULTS WITH THEIR AIA-900 INSTRUMENT WERE SEEN BETWEEN (B)(6) 2018. THE CUSTOMER PERFORMED THE QUARTERLY DECONTAMINATION PROCEDURE AND QUALITY CONTROLS (QC) WERE WITHIN TARGET RANGES. THE CUSTOMER STATED NOT SEEING <25 PG/ML PATIENT RESULTS AFTER PERFORMING THE ROUTINE QUARTERLY DECONTAMINATION ON THE AIA-900 INSTRUMENT. THE TECHNICAL SUPPORT SPECIALIST (TSS) REQUESTED FIVE (5) SAMPLES TO BE SENT TO THE TOSOH QUALITY ASSURANCE (QA) LAB FOR CORRELATION WITH A DIFFERENT AIA-900 INSTRUMENT. THERE IS NO INDICATION OF ANY ADVERSE HEALTH IMPACT TO PATIENT MANAGEMENT DUE TO THESE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679493 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1