BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-600II

    MDR report key: 7344202 · Received March 15, 2018

    Report

    Report Number
    3005529799-2018-01281
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    July 22, 2016
    Report Date
    March 15, 2018
    Manufacturer
    TOSOH BIOSCIENCE, INC.
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS DISPATCHED TO THE FIELD SERVICE ENGINEER (FSE) DEPARTMENT ON THE (B)(4) 2016 FOR FURTHER INVESTIGATION. DURING THE INVESTIGATION THE FSE DECONTAMINATED THE WASH AND DILUENT SYSTEMS WITH 10% BLEACH AND REPLACED THE SUBSTRATE SYRINGE. ALSO, THE FSE CHECKED THE WASH BUSHING AND WASH SYSTEM. THEN CLEANED OUT THE NOZZLE AND MADE SURE NO OBSTRUCTIONS ARE INSIDE OF IT. THE FSE RAN MAC CONTROLS LOT F305 AND TWO DIFFERENT LOTS OF BIO RAD CONTROLS AFTER CALIBRATION. ONE OF THE BIO RAD LOTS WAS WITHIN RANGE BUT ON THE UPPER END OF THE RANGE WHILE THE OTHER LOT OF BIO RAD CONTROL WAS OUT HIGH. THE MAC CONTROLS WERE WITHIN RANGE. BIO RAD LOT # 23620: (B)(6). MAC LOT # F305: (B)(6). THE MOST PROBABLE CAUSE FOR THIS EVENT IS CONTROL RANGE ADJUSTMENT. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-(B)(4).

    Description of Event or Problem · 1

    ON THE (B)(6) THE CUSTOMER REPORTED TROPONIN QC L1 HIGH ON BIO RAD 23580 AND MAC. THE CUSTOMER STATED THAT THE TTR RANGES AS FOLLOW: 23581 = 0.17-0.51; 23582= 5.97-9.95; 23583= 35.2-58.7. THE TROPONIN CONTROL LOT 53 WAS USED DURING THE RUN, AND THE CALIBRATOR LOT IS UNKNOWN. THE CALIBRATION DATE WAS (B)(6) 2016. THE CAL 1 AND CAL 6 WERE AS FOLLOW: CALIBRATOR 1 RATES WERE= 0.087, 0.77, 0.87; CALIBRATOR 6 RATE WERE = 106.13, 107.245, 107.398. THE BIO RAD CONTROL 23581 SHIPPED ON 6-20-2016 HAD RATES OF 0.6, 0.49, 0.54, AND 0.50. AND FOR THE SAME BIO RAD CONTROL SHIPPED ON 7-19-2016 HAD RATES 0.55, 0.58 AND 0.53. THE RESULTS WERE THE SAME OUT HIGH WITH TTR ON BOTH SHIP DATES. TROPONIN CONTROL LOT 54 WITH CALIBRATOR LOT 68 WHICH WAS CALIBRATED ON (B)(6) 2016 HAD RATES FOR CAL 1= 0.082, 0.070, 0.083 AND FOR CAL 6 RATES WERE 123.669, 124.245, AND 125.635. THE BIO RAD 23581 RESULT WAS 0.49 WHICH IS WITHIN WITH TTR. THE OLD TROPONIN CONTROL LOT 53 WITH CALIBRATOR LOT 69 WHICH WAS CALIBRATED ON (B)(6) 2016 THE CAL 1 RATES WERE 0.06, 0.08, 0.08 AND CAL 6 RATES WERE 132, 133, 131. ALL BIO RAD 23580 CONTROLS WERE WITHIN RANGE. THE TECHNICAL SUPPORT GROUP (TSG) ADVISED THE CUSTOMER TO CLEAN OR REPLACE THE WASH PROBE TIP AND RECALIBRATE WITH A NEW CALIBRATOR LOT TO BRING THE RATES UP. THE CUSTOMER PERFORMED AN INVESTIGATIONAL RUN FOR TROPONIN USING CALIBRATOR LOT 70 AND RECALIBRATED WITH TROPONIN CONTROL LOT 53. ALSO, BIO RAD 23580 AND MAC WERE INCLUDED IN THE RUN. THE RATES FOR THE CALIBRATORS WERE AS FOLLOW 0.089, 0.26, 2.60, 8.47, 35.67, AND 137.67. THE MAC RUN WAS IN TRIPLICATES AND THE RESULTS WERE AS FOLLOW: LEVEL 1 = 0.30, 0.27, 0.24, RANGE IS 0.13-0.31 MEAN IS 0.22. LEVEL 2 = 7.58, 7.62, 7.78, IN RANGE, RANGE IS 5.20-9.66, MEAN IS 7.43. LEVEL 3 = 16.49, 15.97, 16.48, IN RANGE, RANGE IS 11.2-20.9, MEAN IS 16.04. THE BIO RAD 23580 RESULTS WERE 0.53 AND 0.49 WHICH ARE OUT OF RANGE HIGH AT THE UPPER LIMIT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING TROPONIN 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
    186241 AIA-600II AIA-600II KHO TOSOH BIOSCIENCE, INC. AIA-600II

    Patients

    Seq Age Sex Outcome Treatment
    1