BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 4698381 · Received April 16, 2015

    Report

    Report Number
    2919069-2015-00018
    Event Type
    Malfunction
    Date Received
    April 16, 2015
    Date of Event
    March 20, 2015
    Report Date
    March 24, 2015
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. FIELD SERVICE REPLACED THE SILICON TUBING, PART NUMBER 9130542, DUE TO BEING WORN OUT FROM NORMAL USE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, THE INSTRUMENT PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY DEPRESSED PLATELET RESULTS ON THE CELL-DYN CD1800 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 16 ON (B)(6) 2015, REPEAT 157 ON (B)(6) 2015. SAMPLE WAS SENT TO REFERENCE LAB AND WAS REJECTED DUE TO CLOTTED SAMPLE. CUSTOMER STATES THAT PATIENT WAS DEFERRED TO A SPECIALIST, BUT NO TREATMENT PROVIDED BASED ON THE INITIAL RESULT. THE INITIAL RESULT WAS GIVEN TO THE PROVIDER TO REVIEW, HOWEVER WAS NOT REPORTED IN THE PATIENT'S CHART. THE REPEAT RESULT OF 157 WAS REPORTED IN THE PATIENT'S CHART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253532 CELL-DYN 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1