BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 70

    MDR report key: 546473 · Received August 20, 2004

    Report

    Report Number
    2432235-2004-00012
    Event Type
    Other
    Date Received
    August 20, 2004
    Date of Event
    June 10, 2004
    Report Date
    July 26, 2004
    Manufacturer
    DREW MWI DANAM
    Product Code
    GKZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 07/2004, BAYER WAS NOTIFIED BY THE CUSTOMER LABORATORY THAT ONE PT HAD BEEN GIVEN 2 UNITS OF RBCS [RED BLOOD CELLS] DUE TO A FALSELY LOW HEMOGLOBIN RESULT ON THE ADVIA 70. THIS EVENT OCCURRED, HOWEVER, IT WAS NOT REPORTED TO BAYER UNTIL 6 WEEKS LATER. THE HEMOGLOBIN RESULT REPORTED WAS 7.5 G/DL. THE HEMOGLOBIN RESULT AFTER THE TRANSFUSIONS WAS 12.5 G/DL. THE PHYSICIAN REQUESTED A REPEAT TEST ON THE ORIGINAL SAMPLE. THE ORIGINAL SAMPLE [PRE-TRANSFUSION] HAD A HEMOGLOBIN RESULT OF 9 G/DL. THE HOSPITAL ALLEGES THAT THEY WOULD HAVE TRANSFUSED ONLY ONE UNIT RATHER THAN TWO UNITS IF THE ORIGINAL RESULT HAD BEEN 9 G/DL. THIS MDR IS BEING FILED BASED ON THE FACT THAT THE PT WAS GIVEN 2 UNITS OF RBCS RATHER THAN 1 UNIT. BAYER SERVICE WAS CALLED 2 WEEKS AFTER EVENT AND A FIELD SERVICFE ENGINEER VISITED THE SITE. A CLOG WAS FOUND THAT APPARENTLY CAUSED ASPIRATION PROBLEMS. BAYER BELIEVES THIS TO BE AN ISOLATED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 70 HEMATOLOGY SYSTEM GKZ DREW MWI DANAM ADVIA 70 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other