BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7119337 · Received December 14, 2017

    Report

    Report Number
    8031673-2017-00171
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    November 14, 2017
    Report Date
    May 11, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: MULTIPLE ATTEMPTS HAVE BEEN MADE BY TOSOH BIOSCIENCE TO OBTAIN PRE AND POST PATIENT RESULTS WITH THE CUSTOMER AND INFORMATION REGARDING WHETHER THERAPY WAS ADJUSTED WITHOUT SUCCESS. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2016 THROUGH (B)(6) 2017. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER SAFETY PRECAUTIONS SECTION, STATES THE FOLLOWING: DILUENT AND WASH SOLUTION TUBING CAUTION LABEL NOTE THAT THE DILUENT AND THE WASH SOLUTION TANKS ARE OF THE SAME SHAPE AND SIZE. BE SURE TO SELECT THE ONE OF THE CORRECT COLOR. SELECTING THE WRONG TANK WILL DIRECTLY AFFECT ASSAY RESULTS. UNDER 4: OVERVIEW OF SYSTEM OPERATION, THE OPERATOR'S MANUAL INDICATES THE FOLLOWING: 4.1 INSTALLING WASH SOLUTION NOTE THAT THE WASH SOLUTION TANK HAS THE SAME SHAPE AND SIZE AS THE DILUENT TANK. BE SURE TO SELECT THE ONE OF THE CORRECT COLOR OF THE WASH SOLUTION TANK TO BE HIGHLIGHTED AS ORANGE. SELECTING THE WRONG TANK WILL DIRECTLY AFFECT ASSAY RESULTS. 4.2 INSTALLING DILUENT TANK NOTE THAT THE DILUENT TANK HAS THE SAME SHAPE AND SIZE AS THE WASH SOLUTION TANK. BE SURE TO SELECT THE ONE OF THE CORRECT COLOR OF THE DILUENT TANK TO BE HIGHLIGHTED AS GREEN. SELECTING THE WRONG TANK WILL DIRECTLY AFFECT ASSAY RESULTS. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO AN OPERATOR INCORRECTLY INSTALLING THE WASH SOLUTION IN PLACE OF THE DILUENT SOLUTION.

    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: NO CONCLUSION IS YET AVAILABLE; INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED RUNNING ABOUT 50+ PATIENT SAMPLES WITH THE INCORRECT DILUENT SOLUTION ON THE AIA-2000 INSTRUMENT. THE CUSTOMER REPORTED THAT THE EVENING SHIFT INSTALLED WASH SOLUTION IN PLACE OF THE DILUENT SOLUTION THE NIGHT BEFORE AND IT WAS NOT DISCOVERED UNTIL ABOUT 50+ PATIENT SAMPLES HAD BEEN RUN ON THE AIA-2000 INSTRUMENT. QUALITY CONTROLS WERE RUN PRIOR TO THE EVENT WITH CORRECT PLACEMENT OF BOTH WASH AND DILUENT SOLUTIONS; IT WAS SOME TIME AFTER THAT THE SWITCH OF SOLUTIONS OCCURRED AND PATIENT SAMPLES WERE RUN. THE CUSTOMER WAS NOT SURE WHETHER THE PATIENT RESULTS WERE REPORTED OUT OF THE LAB. THE TECHNICAL SUPPORT SPECIALIST (TSS) ASKED WHAT ASSAY WAS BEING RUN AT THE TIME OF THE INCIDENT AND THE CUSTOMER STATED THAT POSSIBLY EVERY ASSAY THAT TOSOH BIOSCIENCE RUNS. THE TSS REQUESTED TO PROVIDE PATIENTS CLINICAL HISTORY, ALL RESULTS BEFORE AND AFTER THE WASH AND DILUENT SOLUTIONS WERE SWITCHED. THE CUSTOMER STATED THAT IT WAS NOT YET FULLY DETERMINED WHICH PATIENTS WERE AFFECTED; THEREFORE, NO REPEAT RUNS HAVE BEEN DONE. THE CUSTOMER WAS DISCUSSING THE ACTIONS TO TAKE WITH THE LAB DIRECTOR. ON (B)(6) 2017 THE CUSTOMER STATED THAT ALL 50+ PATIENT SAMPLES WERE REPEATED AND THAT THERE WERE ABOUT 5 OR 6 PATIENT RESULTS THAT HAD TO BE RE-ADJUSTED FOR RESULTS, BUT STATED THAT THEY WERE MINOR CORRECTIONS. MULTIPLE ATTEMPTS HAVE BEEN MADE BY TOSOH BIOSCIENCE TO OBTAIN PRE AND POST PATIENT RESULTS WITH THE CUSTOMER AND INFORMATION REGARDING WHETHER THERAPY WAS ADJUSTED WITHOUT SUCCESS. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897762 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1