BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7262653 · Received February 11, 2018

    Report

    Report Number
    8031673-2018-00053
    Event Type
    Malfunction
    Date Received
    February 11, 2018
    Date of Event
    January 4, 2018
    Report Date
    February 11, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION BY MANUFACTURER: A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS FOR THE AIA-900, SERIAL NUMBER (B)(4), WAS PERFORMED FROM 12-DEC-2016 THROUGH (B)(6) 2018. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE ST AIA-PACK TESTOSTERONE ASSAY SPECIFICATIONS UNDER LIMITATION OF THE PROCEDURE, PAGE 8, STATES THAT 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.). CERTAIN MEDICATIONS MAY INTERFERE WITH ASSAY PERFORMANCE. ALL RESULTS SHOULD BE INTERPRETED WITH RESPECT TO THE CLINICAL PICTURE OF THE PATIENT. PROBABLE CAUSE WAS INTERFERING SUBSTANCE ON THE PATIENT IN QUESTION DUE TO MEDICATIONS BEING ADMINISTERED. H.10. ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2018 A CUSTOMER REPORTED A DISCREPANT TESTOSTERONE RESULT ON A FEMALE PATIENT SAMPLE ON THE AIA-900 INSTRUMENT. THE TESTOSTERONE PATIENT RESULT, DRAWN ON (B)(6) 2018, WAS 238 NG/DL (REFERENCE RANGE 10 - 73.2 NG/DL) WITH THE AIA-900 INSTRUMENT; THE SAMPLE WAS SENT OUT FOR CONFIRMATION AT (B)(6) WITH A TESTOSTERONE RESULT OF 78 NG/DL WITH AN IMMUNO-ASSAY METHODOLOGY. THE PATIENT WAS REDRAWN ON (B)(6) 2018 AND THE TESTOSTERONE RESULT OBTAINED WITH THE AIA-900 INSTRUMENT WAS 209 NG/DL AND 72 NG/DL AT (B)(6) WITH A MASS SPECTROMETRY (REFERENCE RANGE 10 - 55 NG/DL). THE CUSTOMER REPORTED THAT QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGE. THE PATIENT IN QUESTION IS A DIAGNOSED TYPE 1 DIABETIC THAT IS CURRENTLY ON MULTIPLE MEDICATIONS: ALBUTEROL , BUPROPION, CLONAZEPAM, CYANOCOBALAMIN, DICYCLOMINE, ERGOCALCIFEROL, FLUTICASONE, GLUCAGON, HYOSCYAMINE, INSULIN DETEMIR, IRON DEXTRAN, LACTOBACILLUS ACIDOPHILUS , LANCETS, LINACLOTIDE, LINZESS, MAGNESIUM, METOCLOPRAMIDE, OMEPRAZOLE, ONDANSETRON, TRAMADOL, TRAZADONE, THYROID, PORK (ARMOUR THYROID), BIOTIN. THE PATIENT IN QUESTION WAS TESTED ON TESTOSTERONE AS PART OF A SERIOUS OF TESTS BEING DONE. THE CUSTOMER DID NOT HAVE ANY FURTHER INFORMATION ON THIS PATIENT. THE CUSTOMER AGREED THAT THERE IS AN INTERFERING SUBSTANCE FROM THE LIST OF MEDICATIONS THE PATIENT IN QUESTION IS CURRENTLY UNDER. THE CUSTOMER REPORTED THAT NO OTHER FEMALE PATIENTS ARE HAVING ISSUES WITH THEIR TESTOSTERONE RESULTS. THERE IS NO INDICATION OF ANY ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCREPANT TESTOSTERONE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105874 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1