BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 8740397 · Received June 27, 2019

    Report

    Report Number
    8031673-2019-00198
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    May 28, 2019
    Report Date
    June 27, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AIA-900 INSTRUMENT, SERIAL NUMBER (B)(4), WAS INSTALLED AT THE ACCOUNT ON 03OCT2018. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FROM 03OCT2018 TO AWARE DATE 28MAY2019. NO OTHER SIMILAR COMPLAINTS WERE IDENTIFIED DURING THE SEARCH PERIOD. THE ST AIA-PACK TESTOSTERONE 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 TESTOSTERONE, THE HIGHEST CONCENTRATION OF TESTOSTERONE MEASURABLE WITHOUT DILUTION IS APPROXIMATELY 2200 NG/DL, AND THE LOWEST MEASURABLE CONCENTRATION IS 10 NG/DL (ASSAY SENSITIVITY). ALTHOUGH THE APPROXIMATE VALUE OF THE HIGHEST CALIBRATOR IS 2200 NG/DL, THE EXACT CONCENTRATION MAY BE SLIGHTLY DIFFERENT. THE ASSAY SPECIFICATION, ASSAY RANGE HIGH, SHOULD BE DEFINED AS THE UPPER LIMIT OF THE ASSAY RANGE, 2200 NG/DL. 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. SAMPLES FROM PATIENTS WHO HAD AN INJECTION OF FLUORESCEIN, WHICH IS USED IN FLUORESCEIN FUNDUS ANGIOGRAPHY, MAY CAUSE FALSELY ELEVATED RESULTS. SAMPLES CONTAINING FIBRIN MAY EXHIBIT EITHER FALSELY ELEVATED OR FALSELY DECREASED RESULTS. FIBRIN MUST BE ELIMINATED IN THE SAMPLE BEFORE ASSAY BEGINS. 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. 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 PROBABLE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GETTING A PATIENT TESTOSTERONE RESULT OF 937 NG/DL ON THE AIA-900 ANALYZER, WHICH DID NOT CORRELATE WITH A RESULT OF 278 NG/DL OBTAINED AT THE REFERENCE LABORATORY (METHODOLOGY UNKNOWN). TECHNICAL SUPPORT SUGGESTED TO REDRAW THE PATIENT AND REPEAT THE TEST; HOWEVER, THE CUSTOMER STATED A PATIENT REDRAW WAS NOT POSSIBLE. ALL QUALITY CONTROLS WERE WITHIN RANGE. THERE WAS NO EVIDENCE OF A DEVICE ISSUE. TECHNICAL SUPPORT ADVISED THE CUSTOMER TO PERFORM A PRECISION STUDY ON THE AIA-900 ANALYZER; HOWEVER, THE CUSTOMER DECLINED. THE REFERENCE LABORATORY WAS UNABLE TO RETEST THE SAMPLE. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534549 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1