BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 7741890 · Received August 2, 2018

    Report

    Report Number
    1628664-2018-00999
    Event Type
    Malfunction
    Date Received
    August 2, 2018
    Date of Event
    July 9, 2018
    Report Date
    August 2, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740001544
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THERE IS NO FURTHER PATIENT INFORMATION PROVIDED BY THE CUSTOMER. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED NO TRENDS RELATED TO DISCREPANT PATIENT RESULTS FOR ANY OF THE PARTS; VALVE, MANIFOLD KIT (PART NUMBER 7-77612-03); VALVE, BYPASS, 2-WAY (PN 7-200607-01); AND WASH CUP, BODY ONLY (ROHS) (PART NUMBER 7-200160-01). A REVIEW OF TICKETS FOR THE ARCHITECT I1000SR FOUND NO SIMILAR COMPLAINTS AND NO TRENDS ASSOCIATED WITH ERRATIC RESULTS. A REVIEW OF THE ARCHITECT I1SR56110 SERVICE HISTORY FOUND NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. THERE HAVE BEEN NO SUBSEQUENT CONTACTS FROM THE CUSTOMER REGARDING DISCREPANT RESULTS SINCE THE FIELD SERVICE ENGINEER (FSE) PERFORMED ON-SITE TROUBLESHOOTING, THAT INCLUDED: CLEANING BUILDUP FROM THE PROBE WASH CUP (PART NUMBER 7-200160-01); REPLACING THE MANIFOLD KIT VALVES (PART NUMBER 7-77612-03) ON THE WASH ZONE; AND REPLACING THE MANIFOLD KIT VALVES AND 2-WAY BYPASS VALVES (PART NUMBER 7-200607-01) ON THE TRIGGER/PRE-TRIGGER MANIFOLD. THE ARCHITECT I1000SR SERVICE AND SUPPORT MANUAL PROVIDES THE REMOVAL AND REPLACEMENT INSTRUCTIONS FOR THE PARTS REPLACED. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AND PROVIDES PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR THE TROUBLESHOOTING OF ELEVATED AND ERRATIC RESULTS, INCLUDING THE TROUBLESHOOTING PERFORMED BY THE FSE. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT I1000SR SERIAL NUMBER (B)(4), OR THE REPLACED PARTS: VALVE, MANIFOLD KIT (PART NUMBER 7-77612-03); VALVE, BYPASS, 2-WAY (PN 7-200607-01); AND WASH CUP, BODY ONLY (ROHS) (PART NUMBER 7-200160-01).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT TROPONIN RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: (B)(6) COLLECTED AT 12:21 ON (B)(6) 2018 GENERATED 0.61NG/ML, THE PHYSICIAN QUESTIONED THE RESULT SO THE SAMPLE WAS RETESTED = 1.84NG/ML; REPEATED IN DUPLICATE ON DIFFERENT ARCHITECT = 0.01 AND 0.02NG/ML. A NEW SAMPLE AT 15:30 ON (B)(6) 2018=0.01 / 0.01NG/ML = NEGATIVE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584048 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740001544

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT STAT TROPONIN-I, LIST # 02K41-27,| LOT # 94978UN18