BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 5243888 · Received November 23, 2015

    Report

    Report Number
    1628664-2015-00302
    Event Type
    Malfunction
    Date Received
    November 23, 2015
    Date of Event
    November 3, 2015
    Report Date
    February 22, 2016
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE ACCOUNT. THE FSE DETERMINED THE WZ MANIFOLD (PART NUMBER 7-96176-05) TO BE THE LIKELY CAUSE DUE TO EXCESSIVE BROWN BUILD UP FOUND ON THE NOZZLES OF WZ MANIFOLD 1. THE MANIFOLD AND THE MANIFOLD VALVES WERE REPLACED TO RESOLVE THE ISSUE. A REVIEW OF THE ARCHITECT I2000SR (SN (B)(4)) SERVICE HISTORY WAS PERFORMED. WEEKLY SITE VISITS WERE CONDUCTED THROUGH DECEMBER 12, 2015 TO INSPECT BOTH WZ MANIFOLDS, AND NO ISSUES WERE OBSERVED. NO CONTRIBUTING FACTOR ON OR AROUND THE DATE OF THE EVENT WAS IDENTIFIED, AND NO SUBSEQUENT OCCURRENCES OF DISCREPANT RESULTS WERE FOUND AFTER THE REPLACEMENT OF WZ MANIFOLD 1 AND THE 4 WZ MANIFOLD VALVES BY THE FSE. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE OR NON-STATISTICAL TRENDS WERE IDENTIFIED. THE ARCHITECT SYSTEMS OPERATIONS MANUAL WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION / DEFICIENCY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A FALSE POSITIVE ARCHITECT B-HCG RESULT OF 132 IU/L WAS GENERATED. THE SAMPLE WAS REPEATED AND A RESULT OF <1.2 IU/L WAS GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772443 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1