BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1700

    MDR report key: 1060042 · Received June 12, 2008

    Report

    Report Number
    2919069-2008-00603
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Report Date
    May 30, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL DYN
    Product Code
    GKZ
    PMA / PMN Number
    K870233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) RECOMMENDED THE CUSTOMER VERIFY THE BUBBLE MIX WAS SUFFICIENT IN THE PRE-MIX CUP AND BOTH TRANSDUCERS; VERIFY ALL SYRINGES CLEAN, SEATED PROPERLY WITH NO DEBRIS OR BUBBLES; CHECK PRE-MIX CUP IS CLEAN, CHECK Y FITTING IS CLEAN AND UNOBSTRUCTED, CLEAN BOTH APERTURE PLATES IN 25% BLEACH SOLUTION FOR 5-10 MINS; PERFORM SUPPLEMENTAL APERTURE PLATE CLEANING AND HEMOGLOBIN (HGB) FLOW CELL CLEANING, AND; REPEAT PRECISION AND IF ALL INSPECT, VERIFY CALIBRATION. THE CUSTOMER WAS CONTACTED 02 JUNE 2008 AND REPORTED THAT AFTER TROUBLESHOOTING, THE PRECISION CV%S WERE OUT OF SPEC AS FOLLOWS: WBC=3.1 (<=2.5); HGB=2.6 (<=1.20); RBC=2.5 (<=1.7). THE CUSTOMER REQUESTED A SVC VISIT. ALL PT TESTING WAS BEING SENT OUT TO REFERENCE LAB UNTIL THE ISSUE IS RESOLVED. THE ABBOTT FIELD SVC REP (FSR) VISITED ON 02 JUNE 2008 AND FOUND THE SYRINGE PUMP ASSEMBLY (100UL) NEEDED TO BE CLEANED AND LUBRICATED. THE SAMPLE PROBE AND WASH BLOCK ASSEMBLY WERE WORN OUT FROM NORMAL USE. THE SAMPLE PROBE WAS REPLACED AS A PRECAUTION AND THE WASH BLOCK ASSEMBLY WAS REPLACED AS A HARD FAILURE. PRECISION WAS VERIFIED: CV% WERE AS FOLLOWS: WBC= 2.1%; RBC=1.6%; HGB=0.5%; MCV=0.3%; PLT=3.5%. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. THE CUSTOMER'S ISSUE IS ADDRESSED IN THE CELL-DYN 1700 SYS OPERATOR'S MANUAL (03H58-01; REV D): THE PT'S HEMOGLOBIN OF 7.7 WAS OUT OF RANGE LOW PER PT REFERENCE RANGES IN APPENDIX B (TABLE B-1, B-3). IT IS UNK IF THE CUSTOMER USES LAB ACTION LIMITS WHICH WOULD GENERATE DISPERSIONAL DATA ALERTS. THE MANUAL STATES THAT A RESULT THAT FALLS OUTSIDE A LAB ACTION LIMIT CAN INDICATE THE NEED FOR THE OPERATOR TO FOLLOW A LAB PROTOCOL, SUCH AS REPEATING THE SAMPLE, PERFORMING A SMEAR REVIEW, OR NOTIFYING A PHYSICIAN. (3-23) IT IS UNK IF THE PT'S SAMPLE WAS REPEATED BEFORE REPORTING OUT. ALSO, SECTION 9 PROVIDES INSTRUCTIONS FOR CLEANING THE APERTURE PLATES, SUPPLEMENTAL APERTURE PLATE CLEANING AND HGB FLOW CELL CLEANING ON PGS 9-21 TO 9-26; 9-39 TO 9-42. THESE ARE NON-SCHEDULED MAINTENANCE PROCEDURES. EXPECTED PRECISION SPECS ARE GIVEN ON PAGE 4-21. SEE ALSO SECTION 3: PRINCIPLE OF OPERATION; OPERATIONAL MESSAGES AND DATA FLAGGING; PARAMETER FLAGGING MESSAGES; DISPERSIONAL DATA ALERTS; 3-23 SECTION 4: PERFORMANCE CHARACTERISTICS AND SPECS: WITHIN SAMPLE PRECISION; HEMOGRAM PARAMETERS; TABLE 4.7: WITHIN SAMPLE PRECISION OF HEMOGRAM PARAMETERS - OPEN MODE; 4-18. THIS IS A FINAL REPORT. END OF REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THEY ARE SEEING IMPRECISION WITH CONTROL VALVES WITH THE MCV PARAMETER TRENDING HIGH ON THE CELL-DYN 1700 ANALYZER. THE CUSTOMER ALSO GAVE AN EXAMPLE OF A RECENT PT SAMPLE GENERATING A HEMOGLOBIN RESULT OF 7.7 G/DL. THE PT WAS SENT TO THE HOSP FOR A POSSIBLE TRANSFUSION. A BLOOD SAMPLE TAKEN AT THE HOSP GENERATED A HEMOGLOBIN RESULT OF "ABOUT" 9.0 G/DL AND THE TRANSFUSION WAS CANCELLED. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) SUGGESTED A NUMBER FO TROUBLESHOOTING PROCEDURES TO TRY. THERE IS NO IMPACT TO PT MGMT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK