BEUDAMED
    FDA Adverse Event Other Summary report: N

    CC CREATININE

    MDR report key: 960366 · Received December 7, 2007

    Report

    Report Number
    2018433-2007-00265
    Event Type
    Other
    Date Received
    December 7, 2007
    Report Date
    November 9, 2007
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    CGX
    PMA / PMN Number
    K981799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 WITH THE USE OF A NEW CLINICAL CHEMISTRY CREATININE REAGENT PACK, DISCREPANT PT RESULTS WERE GENERATED ON THE ARCHITECT C8000 ANALYZER. CREATININE RESULTS OF 454 AND 146 UMOL/L WERE GENERATED ON A PT SAMPLE. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CC CREATININE QUANTITATIVE DETERMINATION OF CREATININE CGX ABBOTT MFG, INC. NA 53073HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR ARCHITECT C8000 ANALYZER LIST#1G06-01