BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 120/2120

    MDR report key: 690220 · Received March 17, 2006

    Report

    Report Number
    2432235-2006-00001
    Event Type
    Other
    Date Received
    March 17, 2006
    Date of Event
    February 20, 2006
    Report Date
    February 22, 2006
    Manufacturer
    BAYER DIAGNOSTICS MFG. LTD.
    Product Code
    GKZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2006 IT WAS REPORTED THAT A PT SAMPLE RUN ON THE ADVIA 120/2120 GAVE AN HGB RESULT OF 5.2 G/DL. EVEN THOUGH THE SYSTEM FLAGGED THIS RESULT WITH A 'CC' CODE (WHICH ALERTS THE USER TO REVEIW THE RESULTS AND TAKE APPROPRIATE ACTION), THE TECHNOLOGIST RELEASED THE RESULT TO THE PHYSIIAN AND THE PT RECEIVED A BLOOD TRANSFUSION. UPON FURTHER DISCUSSION WITH THE CUSTOMER, THEY ACKNOWLEDGED THAT THE INITIAL RESULT WAS FLAGGED AND THE TECH SHOULD HAVE REPEATED THE SAMPLE AT THAT TIME TO VERIFY THE RESULTS. SUBSEQUENT TESTING OF THE ORIGINAL SAMPLE 3 DAYS LATER, GAVE A HGB RESULT OF 11.0G/DL. THE CORPUSCULAR HEMOGLOBIN CONCENTRATION MEAN (CHCM) AND MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC) BOTH PROVIDE A MEASUREMENT OF THE AVERAGE CORPUSCULAR HEMOGLOBIN CONCENTRATION IN THE SAMPLE. THE CHCM IS A DIRECTLY MEASURE PARAMETER BASED ON CELL BY CELL ANALUSIS, WHILE THE MCHC IS A CALCULATED PARAMETER BASED ON HGB, MCV AND RBC RESULTS. IF THEY DIFFER BY MORE THAN 1.9 G/DL, A COMPARISON ERROR MCHC/CHCM (CHCMCE) SAMPLE/SYSTEM FLAG ALERTS OPERATORS TO A CONDITION THAT COULD BE AFFECTING ONE OR MORE OF THE THREE RESULTS (RBC, MCV, OR HGB) USED TO CALCULATE MCHC. DOCUMENTATION IN THE OPERATORS MANUAL STATES THAT WHENEVER SUCH FLAGS ARE TRIGGERED,THE USER SHOULD REVIEW THE RESULTS AND TAKE APPROPRIATE ACTION. FOR MED DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 120/2120 HEMATOLOGY SYSTEM GKZ BAYER DIAGNOSTICS MFG. LTD. ADVIA 120/2120 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other