BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT C8000

    MDR report key: 798875 · Received December 18, 2006

    Report

    Report Number
    1628664-2006-00098
    Event Type
    Other
    Date Received
    December 18, 2006
    Date of Event
    November 24, 2006
    Report Date
    November 27, 2006
    Manufacturer
    ABBOTT MANUFACTURING, INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE CALL RESULTED IN THE TECHNICAL EXECUTIVE PERFORMING REGULARLY SCHEDULED PREVENTIVE MAINTENANCE PROCEDURES. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. THE ARCHITECT C8000 SYSTEM SERVICE AND SUPPORT MANUAL (96750-112) INCLUDES A TABLE FOR MAINTENANCE PROCEDURES THAT ARE SCHEDULED FOR 4 MONTHS, 8 MONTHS, AND 12 MONTHS POST INSTALLATION AND AT THE ANNIVERSARY DATES OF THESE SCHEDULED DATES. THE INVESTIGATION DEMONSTRATED THAT THE ARCHITECT C8000 ANALYZER IS PERFORMING WITHIN ITS INTENDED USE, LABEL CLAIMS AND SPECIFICATIONS. NO DEFICIENCY RELATED TO THE PERFORMANCE OF THE DEVICE WAS IDENTIFIED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE PT WAS SEEN AT THE FRACTURE CLINIC (AS AN OUTPATIENT) AND PRESENTED WITH MULTIPLE JOINT PAIN. A SAMPLE TAKEN FROM THE PT ON 22 NOVEMEMBER 2006 WAS TESTED WITH THE ARCHITECT C8000 CALCIUM ASSAY ON 24 NOVEMEBER 2006 AND GENERATED A RESULT OF 13.84 MG/DL (3.46 MMOL/L). SAMPLES ARE ROUTINELY RETESTED AND THIS SAMPLE GENERATED REPEAT TEST RESULTS OF 12.00 MG/DL (3.00 MMOL/L) AND 17.84 MG/DL (4.46 MMOL/L). THIS LAST RESULT WAS REPORTED TO THE PHYSICIAN. THE PT WAS ADMITTED TO THE HOSPITAL WHERE ANOTHER SAMPLE WAS DRAWN. THIS SAMPLE GENERATED A CALCIUM RESULT OF 9.20 MG/DL (2.30 MMOL/L). THE INITIAL SAMPLE WAS ALSO RETESTED ON ANOTHER ANALYZER AND GENERATED A RESULT OF 9.12 MG/DL (2.28 MMOL/L). THERE IS NO FURTHER INPACT TO PT MANAGEMENT REPORTED. A SERVICE CALL WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR CC CALCIUM ASSAY LIST#: 7D61-20, LOT#: UNK