BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 1700

    MDR report key: 736748 · Received June 17, 2005

    Report

    Report Number
    2919069-2005-00041
    Event Type
    Other
    Date Received
    June 17, 2005
    Date of Event
    May 21, 2005
    Report Date
    June 13, 2005
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE CUSTOMER TECHNICAL ADVOCATE (CTA) IN 5/05 TO REPORT IMPRECISION PROBLEMS ON THE CELL-DYN 1700 SYSTEM. ONE PT SPECIMEN COLLECTED AT 2:20 PM ON 5/21/2005 WAS TESTED THREE TIMES. THE RESULT OF THIS SPECIMEN WAS REPORTED OUT OF THE LAB, AND QUESTIONED BY THE PHYSICIAN. A REPEAT ANALYSIS WITH A SAMPLE DRAWN AT 2:46 PM FROM THE SAME PT REVEALED DIFFERENT RESULTS. QC FOR THE LOW CONTROL WAS OUT OF RANGE (LOW) FOR THE HEMOGLOBIN PARAMETER. A PRECISION STUDY WAS PERFORMED IN 5/05, AND THE WBC PARAMETER DID NOT MEET THE PRECISION SPECIFICATION. THE CUSTOMER STATED THAT THE ASPIRATION PROBE HAS BEEN LEAKING, AND THE LEAKING FLUID WAS BLOODY. THE WASH BLOCK WAS REPLACED APPROX 1 MONTH AGO POSSIBLY DUE TO A CLOT IN THE WASH BLOCK VACUUM LINE, PREVENTING ASPIRATION OF DILUENT TO CLEAN THE PROBE, AND THUS RESULTING IN IMPRECISION. THE CTA ASSISTED THE CUSTOMER WITH TROUBLESHOOTING BUT COULD NOT RESOLVE THE ISSUE. FIELD SERVICE WAS DISPATCHED. UPON ARRIVAL AT THE CUSTOMER SITE, THE TECHNICAL EXECUTIVE (TE) OBSERVED THE LEAK FROM THE SAMPLE SYRINGE (DRIPS AND SPRAY), AND THUS HE REPLACED THE SAMPLE SYRINGE, 0.1ML (LIST NUMBER 28514-01) FOR THE RESOLUTION OF THE IMPRECISION PROBLEM. THERE WAS NO FURTHER CONTACT FROM THIS ACCOUNT REGARDING THE SAME ISSUE. TRENDING ANALYSIS: A REVIEW OF COMPLAINT REPORTS FOR THE MONTHS OF MARCH, APRIL AND MAY 2005 DID NOT INDICATE ANY ADVERSE TRENDS ASSOCIATED WITH IMPRECISION DUE TO THE LEAKING SAMPLE SYRINGE ON THE CELL-DYN 1700CS SYSTEM, LIST # 03H53-01.

    Description of Event or Problem · 1

    THE PRECISION PROBLEM WAS SEEN IN CONTROL DATA AND PT DATA. THE PT SPECIMEN COLLECTED AT 02:20 ON 5/21/2005 WAS RUN THREE TIMES. AN INITIAL RUN GENERATED WBC=1.9 K/UL, HGB=4.6 G/DL AND PLT=13 K/UL. A SECOND RUN GENERATED WBC=0.1 K/UL, HGB=0.1 G/DL AND PLT=0 K/UL. A THIRD RUN GENERATED WBC=1.6 K/UL, HGB=4.2 G/DL AND PLT=14 K/UL. A PHYSICIAN QUESTIONED THE RESULTS FOR THIS PT. A DIFFERENT SAMPLE COLLECTED AT 02:46 ON 5/21/05 GENERATED WBC=6.9 K/UL, HGB=13.0 G/DL AND PLT=151 K/UL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1700 AUTOMATED HEMATOLOGY ANALYZER JJE ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR 08H19-01 CD17K LYTIC AGENT LOT #2409212| 08H17-01 CD17/1800 DILUENT LOT #2360I2