BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1700 CS ANALYZER

    MDR report key: 1984322 · Received February 10, 2011

    Report

    Report Number
    2919069-2011-00035
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K870233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A CLOG AT THE PRE-MIX CUP WAS SUSPECTED. THE CUSTOMER WAS INSTRUCTED TO WASH THE PRE-MIX CUP WITH DILUTED BLEACH AND MONITOR THE ISSUE. THE CUSTOMER CONFIRMED THAT THERE WERE NO FURTHER ISSUES AFTER COMPLETING THE RECOMMENDED ACTIONS. THE ISSUE WAS LIKELY CAUSED BY DEBRIS IN THE PRE-MIX CUP. THE CELL-DYN 1700 SYSTEM OPERATOR'S MANUAL PROVIDES BASIC TROUBLESHOOTING INFORMATION FOR PROBLEM IDENTIFICATION, ISOLATION, AND CORRECTIVE ACTION. INSTRUCTIONS FOR OBTAINING TECHNICAL ASSISTANCE ARE INCLUDED AS WELL. A NON-STATISTICAL TREND (NST) COMPLAINT REVIEW WAS PERFORMED FOR THE REPORTED ISSUE FROM (B)(4) 2010 THROUGH (B)(4) 2011. NO NST WAS IDENTIFIED DURING THE SEARCHED PERIOD. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN 1700 RELATED TO THE REPORTED ISSUE. THE ISSUE WAS ISOLATED TO DEBRIS IN THE PRE-MIX CUP AREA, WHICH WAS RESOLVED BY CLEANING.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. AN INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED DISCREPANT RESULTS WERE GENERATED ON THE CELL-DYN 1700 ANALYZER. A PATIENT SAMPLE WAS TESTED THREE TIMES AND GENERATED HEMOGLOBIN RESULTS OF 5.0, 10.3 AND 15.9 G/DL. WHEN THE SPECIMEN WAS TESTED A FOURTH TIME, THE VALUE WAS VERY SIMILAR TO THE PREVIOUS RESULT OF 15.9 G/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1