BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT CLINICAL CHEMISTRY TOTAL BILIRUBIN

    MDR report key: 950665 · Received November 15, 2007

    Report

    Report Number
    2018433-2007-00236
    Event Type
    Other
    Date Received
    November 15, 2007
    Date of Event
    November 1, 2007
    Report Date
    November 1, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    MQM
    PMA / PMN Number
    K060574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE NEONATE GENERATED THE FOLLOWING ARCHITECT C8000 TOTAL BILIRUBIN ASSAY RESULTS: AT 17:30 HRS= 364 UMOL/L (CAPILLARY DRAW): AT 20:50 HRS= 467 UMOL/L (RETESTED AT 426 UMOL/L; VENOUS DRAW); 21:52 HRS= 369 UMOL/L (CAPILLARY DRAW); 02:15 HRS= 301 UMOL/L (CAPILLARY DRAW); AND AT 06:06 = 297 UMOL/L (CAPILLARY DRAW). THERE IS NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT CLINICAL CHEMISTRY TOTAL BILIRUBIN QUANTITATION OF TOTAL BILIRUBIN MQM ABBOTT MANUFACTURING, INC. NA 54094HW00

    Patients

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