BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD1700 CS

    MDR report key: 667520 · Received January 18, 2006

    Report

    Report Number
    2919069-2006-00005
    Event Type
    Other
    Date Received
    January 18, 2006
    Date of Event
    December 22, 2005
    Report Date
    January 17, 2006
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL IDENTIFIERS (S): 060/1-163016463-11 PATIENT CODE: 2199 (PATIENT, NO CONSEQUENCES TO). DEVICE CODE: 2456 (INACCURATE TEST RESULTS) THE CUSTOMER TECHNICAL ADVOCATE SUGGESTED THAT THE CUSTOMER CLEAN THE CLOSED MODE OPERATION ASSEMBLY WITH BLEACH, FOLLOWED BY A DISTILLED WATER FLUSH. THE CUSTOMER ALSO REPLACED THE CLOSED MODE ASSEMBLY PUMP TUBING AND RAN SUCCESSFUL BACKGROUND COUNTS WITH CONTROLS. THE CUSTOMER ALSO PERFORMED A PRECISION RUN WITH 6 REPLICATES AND ALL RESULTS REPRODUCED WITHIN EXPECTED SPECIFICATIONS. THE CUSTOMER REQUESTED NO FURTHER ASSISTANCE. NO FURTHER ISSUES IDENTIFIED. THE CELL-DYN 1700 SYSTEM OPERATOR'S MANUAL, REVISION D: SECTION 10: TROUBLESHOOTING AND DIAGNOSTICS: TROUBLESHOOTING GUIDE: ABNORMAL OR ERRATIC HGB, MCH AND/OR MCHC RESULTS: PG 10-13, PROVIDES INSTRUCTIONS IN REGARDS TO THIS ISSUE ON CLEANING AND THE REPLACEMENT OF ASPIRATION TUBING. THIS INVESTIGATION DEMONSTRATED THAT THE CELL-DYN 1700 CS ANALYZER IS PERFORMING WITHIN ITS INTENDED USE, LABEL CLAIMS AND SPECIFICATIONS; NO DEFICIENCY RELATED TO THE PERFORMANCE OF THE DEVICE WAS IDENTIFIED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CELL-DYN 1700 CS GENERATED VERY LOW RESULTS FOR ALL PARAMETERS ON TWO DONOR SAMPLES. THE RESULTS WERE FLAGGED AS "L" OR "LL" INDICATING THAT THE RESULTS WERE OUTSIDE OF THE LAB'S ESTABLISHED REFERENCE RANGES. THE CUSTOMER PERFORMED AN AUTO-CLEAN PROCEDURE ON THE ANALYZER AND RAN CONTROLS, WHICH TESTED WITHIN SPECIFICATION. HOWEVER, PATIENT #2 GENERATED AN INITIAL HEMOGLOBIN RESULT OF 3.2 G/DL THAT RETESTED AT 14.4 G/DL WITH ALL OTHER PARAMETERS ALSO TESTING WITHIN THE LAB'S NORMAL REFERENCE RANGE. THE CUSTOMER SUGGESTED A NUMBER OF TROUBLESHOOTING PROCEDURES FOR THE CUSTOMER TO TRY. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD1700 CS AUTOMATED HEMATOLOGY ANALYZER GKL ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN