BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 8756195 · Received July 2, 2019

    Report

    Report Number
    8031673-2019-00224
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    June 5, 2019
    Report Date
    October 8, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE RESULTS OF THE FIELD SERVICE ENGINEER'S ONSITE SERVICE OF THE INSTRUMENT, THE PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILURE OF THE 2-WAY SOLENOID VALVE 402. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS AT CUSTOMER SITE TO ADDRESS THE REPORTED EVENT. THE FSE WAS ABLE TO CONFIRM THE IMPRECISION ON CTNL 2 QC FROM THE PRINTOUTS. THE FSE REPRODUCED THE IMPRECISION BY RUNNING CTNL 2 QC. THE FSE RAN CTNL 2 PRECISION ON BIO-RAD (BR) QC (LOT NUMBER 23691), THE-PRECISION VALUE WAS 1.49% (CV), WHICH WAS HIGH. THE FSE RAN CTNL 2 PRECISION USING A DIFFERENT BOTTLE OF SAME LOT OF BR QC AND THE RESULTS WERE 0.33% AND 0.35% (CV). THE FIRST BR QC BOTTLE APPEARED TO BE BAD. THE FSE THEN MADE A NEW BOTTLE OF BR QC (LOT NUMBER 23691) AND RAN PRECISION. THE RESULTS WERE CV=11%. THE FSE THEN RAN MAC QC L1 AND L2 -- WITH CV RESULTS OF ALSO 11%, AND 2.6% RESPECTIVELY; WHICH WERE OUTSIDE OF PUBLISHED RANGE. THE FSE INSPECTED THE PUMP TRAY AND FOUND THAT THE TUBING TO WASTE 2-WAY SOLENOID VALVE 402 WAS CRIMPED AND THE O-RING OF WASTE VALVE WAS BROKEN AND STICKING OUTSIDE OF THE VALVE. THE FSE REPLACED THE TUBING AND THE 2-WAY SOLENOID VALVE 402 AND RE-RAN THE CONTROLS. THE RESULTS FOR CTNL 2 PRECISION ON BR QC (23691), AND MAC 1 QC WERE BOTH IN RANGE. THE RESULTS FOR CTNL 2 PRECISION ON BR QC (23691), AND MAC 1 QC WERE BOTH IN RANGE. THE CUSTOMER CALLED AFTER THE FSE ONSITE VISIT AND STATED THAT THE QUALITY CONTROLS (QC) RECOVERED NEAR THE MEAN AFTER THE REPAIR AND RECALIBRATION. THE CALIBRATION RATES INCREASED AFTER THE REPAIR, WHICH INCREASED THE CONTROLS. TECHNICAL SUPPORT (TS) DISCUSSED THE CALIBRATION RATES AND PROVIDED TRAINING. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-360 INSTRUMENT IS FUNCTIONING AS EXPECTED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4) FROM 05MAY2018 THROUGH AWARE DATE (B)(6) 2019. THERE WAS ONE OTHER SIMILAR COMPLAINT IDENTIFIED DURING THE REVIEW PERIOD. THE ST CTNI2 ANALYTE APPLICATIONS MANUAL STATES THE FOLLOWING: QUALITY CONTROL PROCEDURE. ASSAY QUALITY CONTROL SPECIMENS AS INSTRUCTED IN THE SPECIFIC OPERATOR'S MANUAL FOR YOUR ANALYZER. IN ADDITION, REFER TO THE AIA SYSTEM OPERATOR'S MANUAL FOR DETAILED INSTRUCTIONS ON DEFINING AND EDITING THE FILES. QUALITY CONTROL MATERIAL TO BE RUN WITH THIS ASSAY IS DEFINED BY INDIVIDUAL LABORATORY POLICY. THE PROBABLE CAUSE OF THE REPORTED ISSUE HAS NOT YET BEEN DETERMINED; INVESTIGATION IS CURRENTLY IN-PROCESS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GETTING HIGH CARDIAC TROPONIN I (CTNL 2) QUALITY CONTROL (QC) RESULTS ON THE AIA-360 INSTRUMENT. THE CUSTOMER RECALIBRATED SEVERAL TIMES DUE TO THE SHIFT IN THE QC RESULTS. TECHNICAL SUPPORT (TS) HAD THE CUSTOMER RUN A PRECISION TEST ON LEVEL 1 CTNL 2 QC. THE CUSTOMER RAN THE SAMPLE 10 TIMES AND THE COEFFICIENT OF VARIATION (CV) WAS 15.5%. TS SENT A BOX OF TEST CUPS AND CALIBRATOR TO THE CUSTOMER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF CARDIAC TROPONIN I (CTNL 2) PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548298 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1