BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3200 CS 110V

    MDR report key: 1023671 · Received April 1, 2008

    Report

    Report Number
    2919069-2008-00491
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K972354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THE NIGHT TECH HAD DONE AN EXTENDED AUTOCLEAN. THE EXTENDED AUTOCLEAN RESOLVED THE ISSUE AND NO FURTHER INCIDENTS HAVE BEEN OBSERVED. IT WAS UNKNOWN IF CONTROLS HAD BEEN REPEATED LATER IN THE DAY. THE LIKELY CAUSE OF THE LOW VALUES WAS AN OBSTRUCTION IN THE PROCESSING PATHWAY CAUSING INSUFFICIENT SAMPLE (SHORT SAMPLE). THE CUSTOMER REPORTED RESULTS WERE "OORL" (OUT OF RANGE LOW), WHICH INDICATES THAT THE INSTRUMENT GENERATED DISPERSIONAL DATA ALERTS (VALUES OUTSIDE THE ACTION LIMITS FOR PT SAMPLES). HOWEVER, NO INSTRUMENT PRINTOUTS WERE PROVIDED TO ILLUSTRATE WHAT ALERTED THE CUSTOMER TO THE ISSUE. THE CD3200 SYSTEM OPERATOR'S MANUAL (REV M), STATES: "IT IS SUGGESTED THAT ONE PT LIMIT SET BE USED TO ENTER INSTRUMENT-SPECIFIC LABORATORY ACTION LIMITS. IF THE INTERPRETIVE REPORT OPTION IS ENABLED, THE INTERPRETIVE MESSAGES, SUCH AS LEUKOCYTOSIS, ANEMIA, THROMBOCYTOPENIA, ETC., WILL BE DISPLAYED WHEN A RESULT FALLS OUTSIDE THE APPROPRIATE LIMIT. A RESULT THAT FALLS OUTSIDE A LABORATORY ACTION LIMIT CAN ALSO INDICATE THE NEED FOR THE OPERATOR TO FOLLOW A LABORATORY PROTOCOL, SUCH AS REPEATING THE SAMPLE, NOTIFYING THE PHYSICIAN OR PERFORMING A SMEAR REVIEW" (PAGE 3-31). THE CD3200 SYSTEM OPERATOR'S MANUAL PROVIDES TROUBLESHOOTING STRATEGIES ON PAGES 10-23, 10-24, 10-27 TO 10-29. PAGE 10-29 PROVIDES A TABLE FOR TROUBLESHOOTING IMPRECISE OR INACCURATE DATA AND INCLUDE INSPECTING / CLEANING SYRINGES, CLEANING THE SHEAR VALVE AND Y VALVE AND CHECKING / CHANGING THE PERISTALTIC PUMP TUBING. MAINTENANCE ACTIVITIES ARE OUTLINED IN SECTION 9. EXTENDED AUTOCLEAN IS A WEEKLY MAINTENANCE ACTIVITY DESIGNED TO REMOVE ANY FIBRIN OR DEBRIS WITHIN THE SYSTEM BY FORWARD AND REVERSE ACTION OF THE PERISTALTIC PUMP. AS THE EXTENDED AUTOCLEAN PROCESS TAKES 2.5 HOURS TO COMPLETE AND CANNOT BE INTERRUPTED ONCE STARTED, THE PROCEDURE IS USUALLY SCHEDULED FOR PERIODS OF LOW USE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT SOME PT SAMPLES TESTED ON THE CELL-DYN 320 CS 110 ANALYZER (OPEN MODE ONLY) ARE GENERATING LOWER VALUES ON THE SAME SAMPLES RUN EARLIER IN THE DAY. THE CUSTOMER ONLY PROVIDED ONE EXAMPLE OF AN EARLIER GENERATED RBC RESULT OF 4.30 M/UL ON A SAMPLE THAT IS NOW TESTING AT VALUES BETWEEN 0.90 AND 2.49 M/UL. THE CUSTOMER STATES THAT A SIMILAR DIFFERENCE IS SEEN IN THE OTHER HEMATOLOGY PARAMETERS (NO FURTHER DATA PROVIDED). NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THE CUSTOMER HAS ALREADY PERFORMED AN AUTO-CLEAN PROCEDURE AND CLEANED THE SHEAR VALVE WITH NO RESOLUTION. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) HAD THE CUSTOMER CLEAN THE OPEN MODE Y-VALVE WITH NO RESOLUTION. THE CTA FURTHER INSTRUCTED THE CUSTOMER TO PERFORM AN OPEN SAMPLE PROBE INTERIOR CLEANING AND IF NO RESOLUTION, TO CLEAN THE SHEAR VALVE AGAIN. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3200 CS 110V AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI