BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1211212 · Received October 28, 2008

    Report

    Report Number
    2919069-2008-00743
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHLEBOTOMIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (PRECISION OF INSTRUMENT WAS IN RANGE. POSSIBLE SAMPLE RELATED ISSUE (MIXING, DRAW TECHNIQUE (FINGER STICK); 400 (POSSIBLE SAMPLE TECHNIQUE OR PROCESSING). AN INVESTIGATION WAS PERFORMED IN RESPONSE TO THE CUSTOMER'S COMPLAINT. THE COMPLAINT WAS INVESTIGATED BY THE REVIEW OF THE COMPLAINT TEXT, REVIEW OF THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL, REVIEW OF THE COMPLAINT INFORMATION ON THE CELL-DYN 1800 PRODUCT AND THE REVIEW OF THE DATA PROVIDED. THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL ((B)(4), REVISION E) UNDER SECTION 5, PAGE 5-52, PROVIDES INFORMATION IN REGARDS TO SPECIMEN COLLECTION. IN THE CASE OF MICRO COLLECTION SPECIMENS, THE MINIMUM VOLUME IS 50 UL. THE CUSTOMER WAS ALSO REFERRED TO THE MANUFACTURER'S PACKAGE INSERT AND THE (B)(6) FOR THE CAPILLARY SPECIMENS. ABBOTT HEMATOLOGY EDUCATIONAL MONOGRAPH; PREVENTION OF PATIENT HEMOGLOBIN ERRORS; IT STATES THAT WHEN HAND MIXING A BLOOD SPECIMEN, IT IS ESSENTIAL TO PRODUCE A UNIFORM SUSPENSION OF THE BLOOD CELLS AND IF THE SPECIMEN IS INSUFFICIENTLY MIXED, AND A SAMPLE IS TAKEN FROM THE TOP OF THE BLOOD, ERRONEOUSLY LOW HEMOGLOBIN AND RBC RESULTS ARE GENERATED, ALONG WITH INCREASED WHITE BLOOD CELLS (WBC) AND PLATELET CONCENTRATIONS. WHEN A SAMPLE IS TAKEN FROM THE BOTTOM OF THE TUBE, ERRONEOUSLY HIGH HEMOGLOBIN AND RBC RESULTS ARE GENERATED WITH LOW WBC AND PLATELET CONCENTRATIONS. A REVIEW OF THE INSTRUMENT'S COMPLAINT HISTORY PERFORMED OVER THE TIME PERIOD OF (B)(6) 2007 TO (B)(6) 2008 DID NOT INDICATE ANY ADVERSE TREND FOR THE CELL-DYN 1800, LIST NUMBER 07H77-01, RELATED TO THE ISSUES WITH DISCREPANT RESULTS WITH FINGERSTICK SPECIMENS. SERVICING OF THE INSTRUMENT BY A FIELD SERVICE REPRESENTATIVE AND A REVIEW OF THE MICRO-COLLECTION TECHNIQUES RESOLVED THE ISSUE. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN 1800 ANALYZER, LIST NUMBER 07H77-01, FOR ISSUE RELATED TO DISCREPANT PATIENT RESULT WITH THE FINGERSTICK SPECIMENS. THIS IS A FINAL REPORT.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE CELL-DYN 1800 ANALYZER GENERATED A HEMOGLOBIN RESULT OF 7.2 G/DL ON ONE PATIENT SAMPLE. THE PATIENT SAMPLE GENERATED A HEMOGLOBIN RESULT OF 12.3 G/DL AT A REFERENCE LABORATORY. THE CUSTOMER STATES THAT THE PATIENT SAMPLE TESTED ON CELL-DYN 1800 ANALYZER WAS COLLECTED BY A CAPILLARY FINGER STICK METHOD, WHILE THE PATIENT SAMPLE TESTED AT A REFERENCE LABORATORY WAS COLLECTED BY VENI-PUNCTURE. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI