BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1517470 · Received October 28, 2009

    Report

    Report Number
    2919069-2009-00363
    Event Type
    Injury
    Date Received
    October 28, 2009
    Date of Event
    October 12, 2009
    Report Date
    October 13, 2009
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    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.

    Additional Manufacturer Narrative · 1

    (B) (4) THE CUSTOMER TECHNICAL ADVOCATE VERIFIED WITH THE CUSTOMER THAT ALL MAINTENANCE WAS UP TO DATE, NO BUBBLES, LEAKS, OR CRUST NOTED WITH THE SYRINGES. THE CUSTOMER REQUESTED A FIELD SERVICE VISIT TO RESOLVE THE ISSUE. ON 13 OCTOBER 2009, A FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE 0.35 ID SILICON TUBING (S1), WHICH WAS PERFORMING PER SPECIFICATIONS. THE FSR INSPECTED THE HGB FLOW CELL FOR LEAKS, VERIFIED QUALITY CONTROLS AND RAN PRECISION TO CONFIRM THE INSTRUMENT WAS OPERATING PROPERLY. THE FSR RAN PATIENT SAMPLES TO COMPARE RESULTS WITH THE CUSTOMER. THE CUSTOMER WAS PRESSING THE TOUCH PLATE AND THEN PUTTING THE TUBE UNDER THE SAMPLE PROBE. THE FSR TRAINED THE CUSTOMER ON PROPER PROCEDURE TO RUN PATIENT SAMPLES. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS, NO FURTHER INVESTIGATION WAS REQUIRED. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN 1800 RELATED TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE CELL-DYN 1800 ANALYZER HAS GENERATED DISCREPANT RESULTS ON 2 PATIENT SAMPLES. FOR PATIENT #1, THE INITIAL RESULT WAS 6.8 G/DL. THE PATIENT WAS TRANSFUSED SINCE THE LAB POLICY FOR TRANSFUSION IS HGB RESULTS OF 8 G/DL OR LOWER. THE SAMPLE WAS THEN SENT TO A REFERENCE LAB, AND THE RESULT WAS 8.2 G/DL. THERE WAS NO FURTHER INFORMATION PROVIDED FOR THIS PATIENT.

    Description of Event or Problem · 1

    THIS MALE PT HAD A CYPHER STENT IMPLANTED IN HIS LEFT ANTERIOR DESCENDING ARTERY (LAD). HE WAS PRESCRIBED PLAVIX FOR THREE MONTHS. AT SOME POINT AFTER THE DISCONTINUATION OF PLAVIX, THE PT SUFFERED IN-STENT THROMBOSIS AND A MYOCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other