BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 2990225 · Received March 5, 2013

    Report

    Report Number
    1628664-2013-00048
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JGS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, EVALUATION OF THE INSTRUMENT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT. THE SODIUM DISCREPANT RESULT ISSUE WAS RESOLVED THOUGH THE PERFORMANCE OF A NORMAL MAINTENANCE PROCEDURE AND THE ICT MODULE PERFORMANCE WAS ACCEPTABLE AFTER THE BLEACHING PROCEDURE WAS PERFORMED. A COMPLAINT REVIEW DID NOT IDENTIFY AN ADVERSE TREND OR A PRODUCT ISSUE RELATED TO THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE EVENT DETAILS AND EVALUATION, NO PRODUCT DEFICIENCY AND NO MALFUNCTION WAS IDENTIFIED WITH THE ARCHITECT C16000 PROCESS MODULE, LN 03L77.

    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 OBSERVED AN ABERRANT SODIUM RESULT WHILE USING THE ARCHITECT C16000 PROCESS MODULE. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS: SID (B)(6): INITIAL 117 MMOL/L, RETEST 136 MMOL/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92758 ARCHITECT C16000 SYSTEM JGS ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 SODIUM| SODIUM