BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT C80000

    MDR report key: 983102 · Received January 17, 2008

    Report

    Report Number
    1628664-2008-00017
    Event Type
    Other
    Date Received
    January 17, 2008
    Date of Event
    December 21, 2007
    Report Date
    December 21, 2007
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED, CREATININE RESULTS WERE NOT REPRODUCIBLE FOR ONE PT TESTED ON THE ARCHITECT C8000 ANALYZER. A CREATININE RESULT OF 44.3 G/L WAS GENERATED AND DID NOT CORRESPOND WITH THE PT'S PREVIOUS MEDICAL HISTORY. THE SAMPLE WAS REPEATED WITH RESULTS OF 9.8 AND 22 G/L. AFTER ASSAY RECALIBRATION, A RESULT OF 10.0 G/L WAS OBTAINED. NO IMPACT TO PT MGMT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C80000 AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MFG, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI CC CREATININE LIST # 7D64-20