BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1628664-2017-00339

    MDR report key: 6865171 · Received September 14, 2017

    Report

    Report Number
    1628664-2017-00339
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Report Date
    October 23, 2017
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS ON TWO PATIENTS. WHEN THE SAMPLES WERE RE-TESTED ON A DIFFERENT ANALYZER THE RESULTS WERE NEGATIVE. DURING A SUBSEQUENT SITE VISIT THE ABBOTT FIELD SERVICE ENGINEER (FSE) OBSERVED THAT THE MANIFOLD KIT VALVE (ROHS) (PART NUMBER 7-77612-03) AND THE 2-WAY BYPASS VALVE (ROHS) (PART NUMBER 7-200607-01) DID NOT WORK PROPERLY. THE FSE REPLACED THESE PARTS WHICH RESOLVED THE ISSUE. A REVIEW OF THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS, AS WELL AS, INFORMATION REGARDING TROUBLESHOOTING ERRATIC/DISCREPANT RESULTS. A REVIEW OF THE ARCHITECT I1SR02087 SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. THERE HAVE BEEN NO SUBSEQUENT CONTACTS FROM THE CUSTOMER REGARDING ERRATIC OR DISCREPANT RESULTS SINCE THE PARTS WERE REPLACED. A REVIEW OF TICKETS FOR THE MANIFOLD KIT VALVE (ROHS) (PART NUMBER 7-77612-03) OR THE 2-WAY BYPASS VALVE (ROHS) (PART NUMBER 7-200607-01) IDENTIFIED NO ADDITIONAL COMPLAINTS OR TRENDS FOR THE ISSUE. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT SN I1SR02087 NOR THE MANIFOLD KIT VALVE (ROHS) OR THE 2-WAY BYPASS VALVE (ROHS).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT TROPONIN RESULTS ON TWO PATIENTS. THERE WERE NO ACTUAL VALUES PROVIDED. THE CUSTOMER REPORTED THE ARCHITECT HS TROPONIN GENERATED POSITIVE RESULTS AND WHEN THE SAMPLES WERE RETESTED ON ANOTHER ANALYZER THE RESULTS WERE NEGATIVE. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I,| LIST # 03P25-26, LOT # UNKNOWN