BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 4713819 · Received April 21, 2015

    Report

    Report Number
    1628664-2015-00137
    Event Type
    Malfunction
    Date Received
    April 21, 2015
    Report Date
    March 27, 2015
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED WHEN THE CUSTOMER OBSERVED DISCREPANT PATIENT RESULTS. THE FSE FLUSHED AND VERIFIED DISPENSE VOLUMES FOR PIPETTOR, TRIGGER AND PRE-TRIGGER AND WASH VOLUMES. HE PERFORMED A PROACTIVE REPLACEMENT OF THE PRE TRIGGER VALVE AND REPLACED THE WASH BUFFER. THE FSE ALSO INDICATED THAT HE OBSERVED "THAT THE CABLE FROM THE BYPASS VALVE ON THE WASH MANIFOLD WAS ACCIDENTLY PLACED UNDER THE WASH MANIFOLD PLATFORM CAUSING MICRO PARTICLES TO BE WASHED OFF THE WALL OF THE RV NEAR THE MAGNETS". THE FSE SURMISED THAT THE CABLE MAY HAVE BEEN SEATED IMPROPERLY WHEN THE CUSTOMER CLEANED THE PROCESS PATH AND CONCLUDED THAT AFTER CHANGING THE VALVE AND BUFFER AND PUTTING THE PROCESS PATH BACK TOGETHER PROPERLY, THE ISSUE WAS RESOLVED. THE VALVE, BYPASS, 2 WAY (PART NUMBER 7-200607-01) WAS NOT AVAILABLE FOR RETURN. A PRODUCT LABELING REVIEW FOUND THE ARCHITECT SYSTEMS OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AND ADDRESSES TROUBLESHOOTING OF ERRATIC/DEPRESSED RESULTS. A REVIEW OF QUALITY METRICS DID NOT IDENTIFY ANY ADVERSE TRENDS WITH THE ISSUE DESCRIBED IN THE COMPLAINT. BASED ON THE RESULTS OF THE INVESTIGATION, THERE IS NO INDICATION OF A DEFICIENCY OF THE VALVE, BYPASS, 2 WAY (PART NUMBER 7-200607-01); THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION OF THE PART BASED ON THE FSE'S ASSESSMENT OF THE ISSUE AND THE CABLE FROM THE BYPASS VALVE BEING ACCIDENTLY PLACED UNDER THE WASH MANIFOLD PLATFORM.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED FALSELY DECREASED PATIENT RESULTS FOR THE TSH ASSAY. THE CUSTOMER PROVIDED DATA FROM THREE PATIENT SAMPLES AS FOLLOWS: ONE PATIENT SAMPLE GENERATED A RESULT OF 0.11 UIU/ML, WHICH WAS REPEATED WITH AN ALTERNATE METHOD AT 1.75 (NORMAL RANGE IS 0.4-4.2). ANOTHER PATIENT SAMPLE GENERATED A RESULT OF 0.11UIU/ML, WHICH WAS REPEATED WITH AN ALTERNATE METHOD AT 1.22 UIU/ML ONE MORE PATIENT SAMPLE GENERATED A RESULT OF 0.11, WHICH WAS REPEATED WITH AN ALTERNATE METHOD AT 0.93 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262946 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 TSH REAGENT