BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 6966836 · Received October 20, 2017

    Report

    Report Number
    8031673-2017-00063
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    September 22, 2017
    Report Date
    January 9, 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

    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. H.3. DEVICE EVALUATION BY MANUFACTURER: UNABLE TO DETERMINE ROOT CAUSE AT THIS TIME; INVESTIGATION INTO THIS ISSUE IS CURRENTLY IN-PROGRESS.

    Additional Manufacturer Narrative · 0

    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. H.3. DEVICE EVALUATION BY MANUFACTURER: UNABLE TO DETERMINE ROOT CAUSE AT THIS TIME; INVESTIGATION INTO THIS ISSUE IS CURRENTLY IN-PROGRESS. G. 3. REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED THAT A PATIENT SAMPLE RAN ON (B)(6) 2017 OBTAINED TEST RESULTS OF 940 PG/ML ON ESTRADIOL (ASSAY RANGE 25 - 3000 PG/ML) AND 1.8 NG/ML (ASSAY RANGE 0.1 - 40 NG/ML) ON PROGESTERONE WITH THE AIA-900 ANALYZER. THE PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE PHYSICIAN BELIEVED THAT THE ESTRADIOL RESULT WAS TOO LOW BASED ON THE PATIENT'S CLINICAL HISTORY. THE PATIENT SAMPLE WAS REPEATED ON ESTRADIOL ON THE SAME DAY AND THE REST RESULT WAS 2593 PG/ML, WHICH THE PHYSICIAN CONFIRMED THAT CORRELATED WITH THE PATIENT'S CLINICAL HISTORY. PROGESTERONE WAS NOT REPEATED AT THIS TIME. THE CUSTOMER REPORTED THAT QUALITY CONTROLS (QC) WERE WITHIN ACCEPTABLE RANGE. THE CUSTOMER REPORTED THAT THERE WERE NO ABNORMALITIES WITH THE PATIENT SAMPLE PRIOR TO BEING RUN ON THE AIA-900 ANALYZER; IT WAS FREE OF FIBRIN. ON (B)(6) 2017 THE CUSTOMER REPEATED THE SAME PATIENT SAMPLE FOR ESTRADIOL AND THE TEST RESULT OBTAINED WAS 2569 PG/ML, WHICH CORRELATED WITH THE SECOND RESULT OF (B)(6) 2017. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT. A FIELD SERVICE ENGINEER WAS DISPATCHED TO ADDRESS THE REPORTED ISSUE.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    (B)(4) PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: A FIELD SERVICE ENGINEER (FSE) FOUND CRUSTY SUBSTANCE ON THE SUBSTRATE TIP. THE FSE CLEANED AND VERIFIED CORRECT SUBSTRATE DELIVERY. THE FSE CHECKED FOR SAMPLING NOZZLE ASSEMBLY WITH NO CORROSION OBSERVED. THE FSE PERFORMED ALIGNMENT FOR WASHER AND SUBSTRATE TO INCUBATOR. THE CUSTOMER PROCEEDED TO RUN QUALITY CONTROLS WITH PASSING RESULTS. THE AIA-900 INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS AFTER COMPLETING THE REPAIR. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE AIA-900, SERIAL NUMBER (B)(4), FROM 22-AUG-2016 THROUGH 22-SEP-2017. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SAFETY PRECAUTIONS STATES THE FOLLOWING: AT SYSTEM SHUTDOWN, REPLACE THE SUBSTRATE SOLUTION REMAINING IN THE SUBSTRATE LINE WITH SUBSTRATE REPLACEMENT SOLUTION (70 % ETHANOL) - IF THE SUBSTRATE SOLUTION REMAINS IN THE SUBSTRATE LINE FOR A LONG TIME, IT MAY PRECIPITATE. PRECIPITATION IN THE SUBSTRATE LINE MAY CLOG THE SUBSTRATE LINE. REPLACEMENT OF THE SUBSTRATE SOLUTION WITH DISTILLED WATER MAY CAUSE CONTAMINATION OF THE SUBSTRATE LINE AND RAISE THE SUBSTRATE BACKGROUND. MAKE SURE TO USE THE SUBSTRATE REPLACEMENT SOLUTION (70 % ETHANOL) AT SYSTEM SHUTDOWN. SECTION 9, SYSTEM SHUTDOWN STATES THE FOLLOWING: 9.2 SHUTDOWN AT THE END OF WORK, BE SURE TO REPLACE THE LIQUID IN THE SUBSTRATE TUBE. IF YOU LEAVE THE SUBSTRATE IN THE TUBE, MOISTURE MAY EVAPORATE AND THE REAGENT MAY DRY OUT IN THE FLOW PATH. ALSO, DEGRADATION OF THE SUBSTRATE MAY CAUSE THE RISING OF BACKGROUND DURING ASSAYS. THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS DUE TO A DIRTY SUBSTRATE DELIVERY NOZZLE.

    Description of Event or Problem · 1

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746733 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1