BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 3882064 · Received June 18, 2014

    Report

    Report Number
    1628664-2014-00120
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE ABBOTT FIELD SERVICE ENGINEER (FSE) WAS INSTALLED A PRESSURE MONITOR SENSOR WHICH WAS WORN OUT FROM NORMAL USE. THE FSE ALSO CLEANED BOTH THE STAT AND SAMPLE PIPETTOR WASH CUPS AS THEY WERE CRUSTED WITH DRY SERUM DEPOSITS. ADDITIONAL FSE ACTIONS INCLUDED BUT WERE NOT LIMITED TO PROACTIVE REPLACEMENT OF THE VALVE MANIFOLD KIT FOR BOTH WASH ZONE 1 AND 2 AND THE TRIGGER AND PRE-TRIGGER DISPENSE VALVES AND CLEANING OF THE MANIFOLDS. THE SYRINGE VALVE WAS ALSO REPLACED AS A PRECAUTION. INSTALLATION OF THE PRESSURE MONITOR SENSOR WAS CONSIDERED TO HAVE RESOLVED THE ISSUE. THE ARCHITECT SYSTEM OPERATIONS MANUAL CONTAINS ADEQUATE INFORMATION FOR TROUBLESHOOTING THE OBSERVED ISSUE. CUSTOMER RETURNS WERE NOT AVAILABLE, BUT CUSTOMER LOGS WERE REVIEWED WITH NO OBVIOUS PROBLEMS FOUND. NO ADVERSE TRENDS WERE IDENTIFIED FOR THE PRESSURE MONITOR SENSOR PART. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED FALSE POSITIVE ARCHITECT BHCG RESULTS ON 2 PATIENT SAMPLES THAT REPEATED NEGATIVE. ID (B)(6) GENERATED POSITIVE ARCHITECT BHCG OF 408.12 IU/L THAT DID NOT MATCH PATIENT CLINICAL HISTORY AND REPEATED ARCHITECT BHCG NEGATIVE AND E170 METHOD NEGATIVE. (B)(6) GENERATED POSITIVE ARCHITECT BHCG OF 359.74 IU/L BUT REPEATED ARCHITECT BHCG NEGATIVE. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358974 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT BHCG LIST 07K78-30| LOT UNKNOWN