BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 2861373 · Received December 7, 2012

    Report

    Report Number
    2919069-2012-00079
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO THE ACCOUNT. THE FSR REPLACED THE RBC/PLT TRANSDUCER DUE TO A BROKEN ELECTRODE CONNECTOR AND COMPLETED PREVENTIVE MAINTENANCE ON THE CELL-DYN 1800 INSTRUMENT. THE DATA SUBMITTED BY THE CUSTOMER HAD HGB VALUES THAT EXCEEDED THE LINEARITY LIMIT, THIS WAS EVIDENT BY THE CHEVRONS (>>>>) IN PLACE OF NUMERICAL VALUES. THE CUSTOMER REPORTED THAT NO FLAGS WERE GENERATED BY THE CELL-DYN 1800 INSTRUMENT; HOWEVER THE DATA DEMONSTRATED THAT PATIENT AND PANIC LIMITS, RM, AND R1 FLAGS WERE GENERATED BY THE INSTRUMENT. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A DEFICIENCY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE CELLDYN 1800 ANALYZER GENERATED ERRATIC HEMOGLOBIN RESULTS ON A FINGERSTICK SAMPLE. RESULTS OF >>>>, >>>>, 5.1 G/DL, 17.7 G/DL AND 14.4 G/DL WERE GENERATED. THE RESULTS WERE NOT REPORTED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1