BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1842662 · Received September 23, 2010

    Report

    Report Number
    1628664-2010-00341
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION FROM THE CUSTOMER INDICATED THAT THE SAMPLE MAY HAVE BEEN FROZEN/THAWED MULTIPLE TIMES. THE CUSTOMER FELT THE LIKELY CAUSE OF THE ERRATIC RESULT WAS RELATED TO SPECIMEN STORAGE AND HANDLING BY THE REFERENCE LABORATORY ALONG WITH DIFFERENCES IN METHODOLOGY. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ARCHITECT INTACT PARATHYROID HORMONE (IPTH) PACKAGE INSERT WERE REVIEWED AND WERE FOUND TO ADEQUATELY ADDRESS THE ISSUE OF ERRATIC RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT I2000SR ANALYZER GENERATED AN INTACT PARATHYROID HORMONE (IPTH) RESULT OF 101.2 PG/ML. THE SAMPLE WAS QUESTIONED BY THE PHYSICIAN AND SENT TO A REFERENCE LAB. A RESULT OF 68.2 PG/ML WAS GENERATED ON THE BAYER CENTAUR ANALYZER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT IPTH RGT 8K25-25, LOT UNKNOWN