BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD1700 CS

    MDR report key: 824500 · Received February 2, 2007

    Report

    Report Number
    2919069-2007-00019
    Event Type
    Other
    Date Received
    February 2, 2007
    Date of Event
    January 8, 2007
    Report Date
    January 8, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    JJE
    PMA / PMN Number
    k870233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED NO INSTRUMENT FLAGS (DIFF FLAGS OR PLT FLAGS THAT WOULD REQUIRE SAMPLE VERIFICATION) BUT COULD NOT PROVIDE INFORMATION REGARDING DISPERSIONAL DATA ALERTS. THE CUSTOMER REPEATED RESULTS BASED ON THE LIS DELTA CHECK USING HISTORICAL DATA. A HGB VALUE OF 4.6 G/DL SHOULD HAVE GENERATED A DISPERSIONAL DATA ALERT. THE CD1700 SYSTEM OPERATOR'S MANUAL RECOMMENDS, ON PAGE 3-23, THAT RESULTS FALLING OUTSIDE ACTION LIMITS (DISPERSIONAL DATA ALERTS) BE CHECKED BY REPEATING THE SPECIMEN, PERFORMING A SMEAR REVIEW, OR NOTIFYING A PHYSICIAN. THE TROUBLESHOOTING SECTION ON PAGE 10-13 FOR ABNORMAL OR ERRATIC HGB, MCH, AND/OR MCHC HAS SUGGESTIONS WHICH INCLUDE: FLOW CELL CLEANING, RETESTING SAMPLE, CHECKING DIAGNOSTICS AND OBTAINING TECHNICAL ASSISTANCE. THE CUSTOMER STATED THAT DAILY MAINTENANCE WAS UP TO DATE. QC WAS ACCEPTABLE IN OPEN AND CLOSED MODES. THE CUSTOMER OBSERVED DURING AUTOCLEAN THAT THE TUBE HOLDER WELL LEAKED A LITTLE. THE CUSTOMER SUSPECTED A SHORT DRAW AS THE SOURCE OF THE ISSUE. TROUBLESHOOTING, PER THE DIRECTION OF THE CTA, FOUND NO INCOMPLETE ASPIRATION ERROR WAS GENERATED WHEN RUNNING THE CLOSED MODE WITH NO SAMPLE.THEREFORE, A FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO CHECK THE INCOMPLETE ASPIRATION SENSOR. THE FSR FLUSHED OUT THE T-FITTING TUBE TO RESOLVE THE ISSUE. THE INSTRUMENT WAS VERIFIED BY RUNNING CONTROLS WHICH PASSED. IN ADDITION THE COMPLAINT ANALYSIS TRENDING SYSTEM (CATS) AND TRENDING ANALYSIS SUPPORT SYSTEM (TASS) REPORTS WERE REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED FOR THE ISSUE OF DISCREPANT RESULTS. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT A LOW HEMOGLOBIN (HGB) RESULT OF 4.6 G/DL WAS GENERATED IN THE CLOSED MODE ON THE CELLDYN 1700 ANALYZER. NO FLAGS WERE GENERATED. THE SAMPLE WAS REPEATED IN THE OPEN MODE AND THE HGB WAS 10.3 G/DL. THE LOW RESULT WAS NOT REPORTED AS IT WAS CONSIDERED SUSPECT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR