BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 1230927 · Received November 17, 2008

    Report

    Report Number
    2919069-2008-00780
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 24, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: SAMPLE-RELATED (SHORT SAMPLE OR INCORRECT MIXING). ON (B)(6) 2008, THE ACCOUNT REPORTED LOW HEMOGLOBIN (HGB) RESULTS TWO PATIENT SAMPLES GENERATED BY THE CELL-DYN SAPPHIRE, (B)(4). IN RESPONSE TO THIS ISSUE AN INVESTIGATION WAS CONDUCTED CONSISTING OF A REVIEW OF THE COMPLAINT TEXT AND ADDITIONAL DATA PROVIDED BY THE CUSTOMER, A SEARCH FOR SIMILAR COMPLAINTS, AN ANALYSIS OF LABELING, AND AN ANALYSIS OF THE CELL-DYN SAPPHIRE INVOLVED IN THE COMPLAINT. UPON REVIEW OF THE DATA FAXED BY THE CUSTOMER, THE CUSTOMER TECHNICAL ADVOCATE (CTA) DISCUSSED THE ISSUE WITH THE CUSTOMER, AS THE ISSUE APPEARED TO BE RELATED TO THE SAMPLE NOT BEING PROPERLY MIXED/ASPIRATED. THE CUSTOMER STATED THAT THE A/L WAS WORKING ROUTINELY AND WITHOUT ERROR. NO MIXHEAD FAILURES OR UNEXPECTED TUBE ERRORS. THE CUSTOMER AGREED THAT THE FIRST SAMPLE SHOULD HAVE BEEN PICKED/CHECKED PRIOR TO THE RELEASE OF THE RESULTS OUT OF THE LABORATORY. THE CTA DISCUSSED WITH THE CUSTOMER THAT THE INITIAL RESULTS FOR BOTH SAMPLES SHOWED PIC/POC FLAG; THE SAMPLES SHOULD HAVE BEEN CHECKED/EVALUATED BY LAB PROTOCOL, I.E. RERUN SAMPLE, MAKE/VIEW BLOOD FILM. THE RESULTS ON THE FIRST PATIENT HAD AN INVALID ABNORMALLY HIGH PLT COUNT, IG FLAG, AND SUSPECT NEU RESULTS. THE SECOND SAMPLE HAD ABNORMALLY LOW RESULTS FOR ALL PARAMETERS WITH PIC/POC DELTA FOR PLT PARAMETERS. THESE RESULTS WOULD REQUIRE VERIFICATION BY THE OPERATOR USING AN ALTERNATE METHOD AND/OR REPEATS, AS STATED IN THE CELL-DYN SAPPHIRE SYSTEM OPERATOR'S MANUAL. ADDITIONALLY, THE SECOND SAMPLE SHOWED RESULTS INDICATING A SHORT SAMPLE. POSSIBLE CAUSES OF SHORT SAMPLES ARE BENT PROBE OR BENT PIERCER NEEDLE. THESE TWO INCIDENTS WERE ISOLATED EVENTS, WHICH COULD POSSIBLY HAVE BEEN CAUSED BY IMPROPER MIXING AND BENT PROBE OR VENT NEEDLE. A DEFINITE CAUSE OF THE LOW HGB COULD NOT BE DETERMINED BASED ON THE DATA SUBMITTED FOR EVALUATION. UPON ON-SITE INSPECTION OF THE CELL-DYN SAPPHIRE, NO PROBLEM WAS OBSERVED. THE INSTRUMENT WAS OPERATING WITHIN SPECIFICATION, AND NO FURTHER DISCREPANT RESULTS HAD BEEN GENERATED BY THE SYSTEM AFTER THIS ISSUE. ADDITIONALLY, THE QUALITY CONTROL SAMPLES WERE WITHIN SPECIFICATION. A REVIEW OF THE TRACKING AND TRENDING SYSTEMS FOR THE PERIOD (B)(6) 2008, DID NOT INDICATE ANY ADVERSE TREND FOR THE CELL-DYN SAPPHIRE, L/N 08H00-01, DISCREPANT RESULTS ON PATIENT SAMPLES. THE CELL-DYN SAPPHIRE SYSTEM OPERATOR'S MANUAL, LIST NUMBER 08H10-01, REVISION D, UNDER SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS, PAGE 10-121, PROVIDES INFORMATION IN REGARDS TO TROUBLESHOOTING DATA-RELATED PROBLEMS. SECTION 7, OPERATIONAL PRECAUTIONS AND LIMITATIONS, LIMITATIONS OF RESULT INTERPRETATION, PAGE 7-10, STATES THAT THE CELL-DYN SAPPHIRE HAS BEEN VALIDATED FOR ITS INTENDED USE. HOWEVER, ERROR CAN OCCUR DUE TO POTENTIAL OPERATOR ERRORS AND CELL-DYN SAPPHIRE SYSTEM TECHNOLOGY LIMITATIONS. RESULTS OBTAINED ON THE CELL-DYN SAPPHIRE MUST BE USED WITH OTHER CLINICAL DATA, FOR EXAMPLE, SYMPTOMS, OTHER TEST RESULTS, PATIENT HISTORY, CLINICAL IMPRESSIONS, INFORMATION AVAILABLE FROM CLINICAL EVALUATION, AND OTHER DIAGNOSTIC PROCEDURES. ALL DATA MUST BE CONSIDERED FOR PATIENT CARE MANAGEMENT. IF THE RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN SAPPHIRE FOR DISCREPANT RESULTS ON PATIENT SAMPLES. THERE WAS NO SYSTEMIC ISSUE FOR THE CELL-DYN SAPPHIRE PRODUCT LINE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT LOW RESULTS WERE RECOVERED FROM PATIENT SAMPLES RUN IN THE CLOSED MODE ON THE CELL-DYN SAPPHIRE ANALYZER. WHEN REPEATED IN THE OPEN MODE, THE RESULTS WERE ACCEPTABLE. THE CUSTOMER STATES THAT WHEN THE PATIENT SAMPLES WERE ANALYZED IN THE CLOSED MODE, NO AUTOLOADER ERRORS OCCURRED DURING THE PROCESSING. THE CUSTOMER PROVIDED FOLLOWING PATIENT DATA:PATIENT 1INITIAL RESULT, CLOSED MODE.WBC = 2.18 K/ULRBC = 2.56 M/ULHEMOGLOBIN = 6.58 G/DLHEMATOCRIT = 0.242 L/LPLATELET = 324 ( INVALID DATA FLAG))REPEAT RESULT, OPEN MODE.WBC = 5.37 K/ULRBC = 3.71 M/ULHEMOGLOBIN = 11.1 G/DLHEMATOCRIT = 0.349 L/LPLATELET = 142NEW SAMPLE, OPEN MODE.WBC = 5.21K/ULRBC = 3.72 M/ULHEMOGLOBIN = 11.1G/DLHEMATOCRIT = 0.351 L/LPLATELET = 189A SERVICE CALL WAS INITIATED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1