BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD 1800 ANALYZER

    MDR report key: 958800 · Received April 24, 2007

    Report

    Report Number
    2919069-2007-00056
    Event Type
    Other
    Date Received
    April 24, 2007
    Date of Event
    April 3, 2007
    Report Date
    April 4, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IN 2007, THE CUSTOMER REPORTED DISCREPANT RESULTS OBTAINED FROM A CELL-DYN 1800. THE PT SAMPLE WAS A FINGERSTICK SAMPLE FROM A 3 YEAR OLD PT. SAMPLE WAS COLLECTED IN A PEDI EDTA MICROTAINER (BULLET). THE WBC/RBC/HGB WERE VERY LOW. PT WAS SENT TO THE HOSPITAL FOR FURTHER TESTING AND ALL RESULTS NORMAL. NO TREATMENT WAS GIVEN TO THE CHILD AS DOCTOR WAITED FOR FOLLOW-UP TESTING FROM THE HOSPITAL. THE PERSON REPORTING THE INCIDENT DID NOT DRAW OR RUN SAMPLE, BUT THE OPEATOR REPORTED THE SAMPLE APPEARED OK. THE FINGERSTICK HAD GOOD FLOW AND APPEARED OK. THE OPERATOR DID NOT REPEAT THE SAMPLE. THE OPERATOR DID NOT KNOW IF THE SAMPLE WAS INSUFFICIENT QUANTITY (QNS) OR JUST DISCARDED. THE CUSTOMER TECHNICAL ADVOCATE (CTA) EXPLAINED THE POSSIBLE ISSUES WHICH CAN OCCUR WITH FINGERSTICK SAMPLES (FIBRIN OR DEBRIS FROM SAMPLING SITE DUE TO TRAUMA AT SAMPLE SITE). THE CTA ALSO INSTRUCTED THE SAMPLE SHOULD HAVE BEEN REPEATED AND CHECKED FOR CLOTS/FIBRIN. THE DISCREPANT RESULT SHOWED LOW RESULTS FOR ALL THE MEASURED PARAMETERS (DISPERSIONAL DATA ALERTS: WBC=3.7 K/UL "L", RBC=1.98 M/UL "L", HGB=5.4 G/DL "LL" AND LOW RESULTS FOR PLATELETS [PLT=143 K/UL; RANGE 140 TO 440 K/UL]). THIS DOES SUGGEST A SHORT SAMPLE, E.G. CLOT OR QNC SAMPLE. THE QC FILES SHOWED THE CONTROLS RECOVERED IN RANGE IN 2007. PER THE CELL-DYN 1800 OPERATOR'S MANUAL, DISPERSIONAL DATA ALERTS INDICATE A NEED TO FOLLOW A LAB PROTOCOL SUCH AS REPEATING THE SAMPLE, PERFORMING A SMEAR REVIEW OR NOTIFYING THE PHYSICIAN. TRENDING: A REVIEW OF COMPLAINT REPORTS, FOR THE PERIOD OCT. 2006 THROUGH MARCH 2007, DID NOT INDICATE ANY ADVERSE TREND FOR CELL-DYN 1800, LIST BASE 07H77-01 FOR ISSUES WITH DISCREPANT RESULTS. THE RESULT WAS REPORTED TO THE PHYSICIAN WITHOUT REPEATING THE SAMPLE OR CHECKING THE SAMPLE FOR CLOSTS/FIBRIN OR VOLUME. THE DEVICE WAS NOT FOUND TO BE OUT OF SPECIFICATION. USER ERROR MAY HAVE CONTRIBUTED TO THE EVENT. NO IMPACT TO PT MANAGEMENT WAS REPORTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT DISCREPANT HEMATOLOGY RESULTS WERE GENERATED FOR ONE PT WHEN USING A CELL-DYN 1800 ANALYZER. THE FOLLOWING RESULTS WERE OBTAINED; WBC=3.7 K/UL, RBC=1.98 M/UL, HGB=5.4 G/DL AND PLT=143 K/UL. RESULTS WERE QUESTIONED BY THE PHYSICIAN AND THE PT WAS SENT TO THE HOSPITAL FOR ADDITIONAL TESTING. HOSPITAL TEST RESULTS; WBC=8.7 K/UL, RBC=4.48 M/UL, HGB=13.1 G/DL AND PLT=463 K/UL. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR LOT NO. UNK.| CD18 HEMOGLOBIN LYSE REAGENT, LIST NO 07H84-02,