BEUDAMED
    FDA Adverse Event Other Summary report: N

    CC NEONATAL BILIRUBIN

    MDR report key: 953927 · Received November 26, 2007

    Report

    Report Number
    2018433-2007-00254
    Event Type
    Other
    Date Received
    November 26, 2007
    Report Date
    October 28, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC
    Product Code
    MQM
    PMA / PMN Number
    K983134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER INQUIRED REGARDING HEMOGLOBIN INTERFERENCE WITH THE ARCHITECT C8000 NEONATAL BILIRUBIN ASSAY. A RESULT OF 34 MG/DL WAS QUESTIONED BY A PHYSICIAN. NO TREATMENT WAS GIVEN BASED ON THE RESULT. THE PT WAS TESTED AT ANOTHER FACILITY USING BECKMAN COULTER XL20 METHOD AND THE RESULT WAS 11 MG/DL. THE PT WAS TESTED AGAIN USING THE ARCHITECT C8000 AND THE RESULT WAS 44 MG/DL. BOTH SAMPLES TESTED ON THE ARCHITECT C8000 WERE HEMOLYZED. PACKAGE INSERT INFO REGARDING INTERFERING SUBSTANCES WAS DISCUSSED WITH THE CUSTOMER. NO IMPACT TO PT MGMT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CC NEONATAL BILIRUBIN QUANTITATIVE MEASUREMENT OF BILIRUBIN IN NEONATAL SERUM OR PLASMA MQM ABBOTT MANUFACTURING, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR ARCHITECT C8000 ALALYZER LIST 1G06-01