BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD1800 ANALYZER

    MDR report key: 899186 · Received August 20, 2007

    Report

    Report Number
    2919069-2007-00128
    Event Type
    Other
    Date Received
    August 20, 2007
    Date of Event
    July 31, 2007
    Report Date
    July 31, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE CUSTOMER STATES THAT THE CELL-DYN 1800 INSTRUMENT GENERATED LOW HGB RESULTS (HGB=5.9 G/DL, HCT=47.5%). THE CUSTOMER TECHNICAL ADVOCATE (CTA) REQUESTED THE CUSTOMER CHECK THE REAGENTS. BOTH DILUENT AND DETERGENT WERE EMPTY AND BUBBLES WERE ALL THROUGH THE TUBING. NO EMPTY REAGENT ALARMS HAD OCCURRED. THE CTA INSTRUCTED THE CUSTOMER TO REMOVE THE LINES FROM THE REAGENT SEVERAL TIMES AND THE EMPTY REAGENT MESSAGES WERE DISPLAYED. THE HGB REFERENCE WAS ADJUSTED FROM 1824 TO 2124 AS A PRECAUTION. THE HGB REFERENCE VALUES SHOULD BE 2000 +/- 200. THE FIELD SERVICE REP (FSR) VISITED THE CUSTOMER SITE AND SERVICED THE HGB FLOW CELL BY ADJUSTING THE VOLTAGE AND ALIGNING THE VP 08 HGB REFERENCE. NO FURTHER INFO WAS OBTAINED FROM THE CUSTOMER. THE CAUSE OF THE EVENT (INSUFFICIENT SPECIMEN SAMPLE, QUALITY OF FINGER STICK SAMPLE, EMPTY REAGENT ALARM, HGB FLOW CELL VOLTAGE OR HGB REFERENCE VALUE) COULD NOT BE DETERMINED. THE CELL-DYN 1800 SYS OPERATOR'S MANUAL ON PAGE 10-41 PROVIDES TROUBLESHOOTING SUGGESTIONS FOR SPURIOUSLY LOW HGB, MCH, OR MCHC RESULTS WHICH INCLUDE CHECKING THE SAMPLE, RERUNNING THE SAMPLE, REDRAWING THE SAMPLE, CLEANING THE FLOW CELL. TRENDING: A REVIEW OF COMPLAINT REPORTS, FOR CELL-DYN 1800, LIST BASE 07H77-01, IN THE PERIOD JANUARY 2007 THROUGH JUNE 2007, DID NOT INDICATE ANY ADVERSE TREND FOR ISSUES WITH LOW HGB RESULTS. LABELING: THE EVENT IS ADDRESSED IN THE CELL-DYN 1800 SYS OPERATOR'S MANUAL, 07H80-01, REV D SECTION 10: TROUBLESHOOTING AND DIAGNOSTICS; INDEX OF ERROR MESSAGES AND CONDITIONS; DATA PROBLEMS; P. 10-41. CONCLUSION: THE DILUENT AND DETERGENT REAGENTS WERE DISCOVERED TO BE EMPTY. THE CUSTOMER STATED THAT THE EMPTY REAGENT ALARM WAS NOT GENERATED. THE EMPTY REAGENT SENSOR, WHEN TESTED, APPEARED TO BE WORKING TO SPECIFICATION. THE HEMOGLOBIN REFERENCE VALUE WAS ADJUSTED AS A PRECAUTION AND HEMOGLOBIN FLOW CELL VOLTAGE WAS ADJUSTED. REFERENCE TEST RESULTS WERE NOT PROVIDED BY THE CUSTOMER. NO IMPACT TO PT MANAGEMENT WAS REPORTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A FINGER STICK SAMPLE FROM ONE PT GENERATED A HGB=5.9 G/DL AND HCT=47.5% USING A CELL-DYN 1800 ANALYZER. A PHYSICIAN HAD QUESTIONED THE RESULTS. THE CUSTOMER STATES THAT BACKGROUND TESTING AND CONTROLS WERE ALL IN RANGE IN THE MORNING PRIOR TO RUNNING THIS PT SAMPLE. THE SAMPLE WAS INSUFFICIENT TO REPEAT THE TESTING AND THE PHYSICIAN SENT THE PT TO A DIFFERENT FACILITY FOR REDRAW AND REPEAT TESTING. THE REPEAT RESULTS FROM THE OTHER FACILITY WERE REQUESTED BUT NOT PROVIDED BY THE CUSTOMER, STATING THAT THEY COULD NOT REMEMBER WHICH PT WAS INVOLVED IN THIS ISSUE. NO PT SPECIFIC INFO WAS PROVIDED. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR CD18 CNF HGB LYSE REAGENT LIST NO. 7H84-01 LOT NO.| DETERGENT LIST NO.8H18-04 LOT NO.49384I2