BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY NEONATAL BILIRUBIN

    MDR report key: 1236291 · Received November 20, 2008

    Report

    Report Number
    2018433-2008-00220
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    November 15, 2008
    Report Date
    November 15, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    MQM
    PMA / PMN Number
    K983134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR: LOT:UNK CLINICAL CHEMISTRY TOTAL BILIRUBIN ASSAY: LOT#: 63013HW00 THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER HAD ONE NEO-NATAL BILIRUBIN PATIENT SAMPLE WITH AN ERRATIC RESULT. THE PATIENT IS A (B)(6) ON INTRALIPIDS AND VITAMIN A SUPPLEMENTS. THE SAMPLE IN QUESTION WAS ALSO TESTED ON ANOTHER ARCHITECT C8000 INSTRUMENT AND GENERATED SIMILAR RESULTS. THE ABBOTT CUSTOMER SERVICE REPRESENTATIVE ADVISED THE CUSTOMER THAT CAROTENOIDS CAUSE POSITIVE INTERFERENCE FOR THE CLINICAL CHEMISTRY NEONATAL BILIRUBIN ASSAY. THEREFORE, THE ERRATIC RESULTS WERE LIKELY DUE TO THE VITAMIN A SUPPLEMENTS. THE CUSTOMER WAS SATISFIED WITH THE EXPLANATION AND REQUIRED NO FURTHER ASSISTANCE. A REVIEW OF THE CLINICAL CHEMISTRY NEONATAL BILIRUBIN PACKAGE INSERT ((B)(6) 2008) STATES: "NOTE: DIRECT SPECTROPHOTOMETRIC BILIRUBIN MEASUREMENT METHODS, SUCH AS ABBOTT CLINICAL CHEMISTRY NEONATAL BILIRUBIN, MEASURE TOTAL BILIRUBIN AND ARE ONLY RECOMMENDED FOR USE WITH PATIENTS (B)(6), AS CAROTENOIDS CAUSE POSITIVE INTERFERENCE". A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE IDENTIFIED. IN ADDITION, A REVIEW OF TRENDING DID NOT IDENTIFY ANY TREND VIOLATIONS FOR THE CLINICAL CHEMISTRY NEONATAL BILIRUBIN ASSAY, (B)(4). THE INVESTIGATION DEMONSTRATED THAT THE CLINICAL CHEMISTRY NEONATAL BILIRUBIN ASSAY 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY NEONATAL BILIRUBIN FOR THE QUANTITATION OF BILIRUBIN IN HUMAN SERUM OR PLASMA MQM ABBOTT MANUFACTURING, INC. 65053HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO ARC C8000 LN:(B)(4)