BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY NEONATAL BILIRUBIN

    MDR report key: 2268218 · Received September 28, 2011

    Report

    Report Number
    1415939-2011-00582
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Date of Event
    September 2, 2011
    Report Date
    September 2, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MQM
    PMA / PMN Number
    K983134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE MDR WAS INADVERTANTLY SUBMITTED WITH THE INCORRECT MANUFACTURER ADDRESS. THE CORRECT SITE LOCATION SHOULD BE ABBOTT MANUFACTURING INC, (B)(4), USA. A NEW MDR WAS SUBMITTED WITH THE CORRECT MANUAFACTURERER INFORMATION AND COMPLETED EVALUATION UNDER MANUFACTURER REPORT 1628664-2011-00678.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED FALSELY ELEVATED ARCHITECT NEONATAL BILIRUBIN RESULT OF 20.2 MG/DL AND REPEATED 20.2 MG/DL ON PATIENT 1 , WHO WAS A (B)(6) FULL TERM INFANT. THE SAME MICROTAINER SAMPLE WAS POURED INTO A CUP WHICH TESTED TOTAL BILIRUBIN OF 10.1 MG/DL. THE SPECIMEN APPEARANCE WAS SLIGHTLY HEMOLYZED BUT CLEAR. ON (B)(6) 2011, PATIENT 1 TESTED NEONATAL BILIRUBIN OF 12.0 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY NEONATAL BILIRUBIN MQM ABBOTT LABORATORIES 69379Y830

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA ARCHITECT C8000, LIST 1G06-01| ARCHITECT C8000, LIST 1G06-01