BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7333150 · Received March 12, 2018

    Report

    Report Number
    8031673-2018-00194
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    February 15, 2018
    Report Date
    March 12, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. ON 16-FEB-2018, A FIELD SERVICE ENGINEER (FSE) REPLACED THE BF PROBE, PERFORMED DAILY BACKGROUND, AND RAN QUALITY CONTROLS (QC). LEVEL 1 OF QC ON CTNL2 WAS WITHIN SPECIFICATIONS. THE AIA-360 INSTRUMENT WAS OPERATIONAL IN ACCORDANCE WITH MANUFACTURER'S SPECIFICATIONS. NO FURTHER ACTION WAS REQUIRED BY THE FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM 15-JAN-2017 THROUGH AWARE DATE (B)(4) 2018. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-360 OPERATOR'S MANUAL UNDER SECTION 7-1: LIST OF ERROR MESSAGES, STATES THE FOLLOWING: IF AN ERROR OCCURS, THE DEVICE STOPS AND THE MESSAGE SHOWN BELOW IS DISPLAYED. IF AN ERROR MESSAGE IS DISPLAYED DURING AN ASSAY, YOU MAY NOT BE ABLE TO CONTINUE THE ASSAY. 2015 BF PROBE PURGE FAILURE. DESCRIPTION: PURGING BY THE BF PROBE IS ABNORMAL. TROUBLESHOOTING: CLEAN UP THE WASH PROBE TIP OR REPLACE IT. CONTACT THE SERVICE DEPARTMENT. THE ST AIA-PACK CTNL 2ND GEN APPLICATION ANALYTE MANUAL UNDER PAGE 8, STATES THE FOLLOWING: EVALUATION OF RESULTS: QUALITY CONTROL: IN ORDER TO MONITOR AND EVALUATE THE PRECISION OF THE ANALYTICAL PERFORMANCE, IT IS RECOMMENDED THAT COMMERCIALLY AVAILABLE CONTROL SAMPLES BE ASSAYED DAILY. THE MINIMUM RECOMMENDATIONS FOR THE FREQUENCY OF RUNNING INTERNAL CONTROL MATERIAL ARE: AFTER CALIBRATION, THREE LEVELS OF CONTROLS ARE RUN IN ORDER TO ACCEPT THE CALIBRATION CURVE. THE THREE LEVELS OF CONTROLS ARE ALSO REPEATED AFTER CALIBRATION WHEN CERTAIN SERVICE PROCEDURES ARE PERFORMED (E.G. TEMPERATURE ADJUSTMENT, SAMPLING MECHANISM CHANGES, MAINTENANCE OF THE WASH PROBE OR DETECTOR LAMP ADJUSTMENT OR CHANGE). AFTER DAILY MAINTENANCE, AT LEAST TWO LEVELS OF THE CONTROL SHOULD BE RUN IN ORDER TO VERIFY THE OVERALL PERFORMANCE OF THE TOSOH AIA SYSTEM ANALYZERS. IF ONE OR MORE CONTROL SAMPLE VALUE(S) IS OUT OF THE ACCEPTABLE RANGE, IT WILL BE NECESSARY TO INVESTIGATE THE VALIDITY OF THE CALIBRATION CURVE AND THE ASSAY RESULTS BEFORE REPORTING PATIENT VALUES. STANDARD LABORATORY PROCEDURES SHOULD BE FOLLOWED IN ACCORDANCE WITH THE REGULATORY AGENCY UNDER WHICH THE LABORATORY OPERATES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A FAULTY BF PROBE ASSEMBLY.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER OUT OF RANGE HIGH QUALITY CONTROLS LEVEL 1 FOR CARDIAC TROPONIN I (CTNL2) WITH THE AIA-360 INSTRUMENT. PRIOR TO CALLING TOSOH TECHNICAL SUPPORT SERVICES, THE CUSTOMER HAD CHANGED THE WASH, DILUENT, AND SUBSTRATE SOLUTIONS, THAWED TWO (2) VIALS OF QC MATERIAL AND RECALIBRATED THE AIA-360. THE CUSTOMER STATED THAT AFTER RECALIBRATION, THE AIA-360 INSTRUMENT GENERATED ERROR MESSAGE 2015 BF PROBE PURGE FAILURE ON ONE (1) PATIENT SAMPLE. THE CUSTOMER REPEATED THE RUN AND THE ERROR DID NOT RECUR. THE TECHNICAL SUPPORT SPECIALIST INSTRUCTED THE CUSTOMER TO RE-RUN QC FOR CTNL2 ALONG WITH A PATIENT FROM THE DAY BEFORE, PRIOR TO THE ISSUE OCCURRING; HOWEVER, THE CUSTOMER REQUESTED SERVICE IN ORDER TO FURTHER INVESTIGATE THE ISSUE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR CTNL2. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175008 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1