BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 2933327 · Received January 29, 2013

    Report

    Report Number
    1628664-2013-00015
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 8, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ISSUE WAS RESOLVED BY PERFORMING SOME MAINTENANCE ACTIVITIES (REPLACING WASH ZONES, MANIFOLD, VTX2, TRIGGER AND PRETRIGGER VALVES). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. SPLASHING OF THE WASH ZONE SOLUTION WAS LATER OBSERVED. THE FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE FEP TIPS WASH ZONE MANIFOLD PARTS (PART NUMBER 7-96176-05) AND MANIFOLD KIT VALVE (PART NUMBER 7-77612-02) WHICH WERE CONSIDERED TO HAVE RESOLVED THE ISSUE. NO TRENDS FOR TICKET WITH REPLACEMENTS FOR THE FEP TIPS WASH ZONE MANIFOLD (PART NUMBER 7-96176-05) WERE IDENTIFIED. THERE WAS NO SYSTEMIC DEFICIENCY OF EITHER PART IDENTIFIED AND THE ISSUE IS ADEQUATELY ADDRESSED IN PRODUCT LABELING. NO MALFUNCTION WAS IDENTIFIED AS THE PARTS WERE REPLACED DUE TO BEING WORN OUT FROM NORMAL USE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED (B)(6) ANTI-HBC II RESULT FROM ONE PATIENT SAMPLE. A (B)(6) RESULT WAS REPEATED (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39647 ARCHITECT I2000 ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT HBC II 8L44-26| ARCHITECT HBC II 8L44-26