BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 2894613 · Received January 3, 2013

    Report

    Report Number
    2919069-2013-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE REPRESENTATIVE ARRIVED AT THE CUSTOMER SITE AND REPLACED THE RINSE HEAD ASSEMBLY DUE TO SALT BUILD UP AND THE CUSTOMER ISSUE WAS RESOLVED. DATA RECEIVED FROM THE CUSTOMER FOR THE SAMPLES IN QUESTION SHOWED THAT LOW RESULTS NOT ONLY IMPACTED THE PLATELET (PLT) PARAMETER, BUT ALL OTHER MAIN PARAMETERS AS WELL. THE MEAN PLATELET VOLUME (MPV) PARAMETER HAD DISPERSIONAL DATA ALERTS, MINUS SYMBOLS (-----) "MEASURAND" FLAGS IN THE RESULT AREA, COUNT INVALIDATION FLAGS, AND AN ASTERISK (*) NEXT TO THE RESULT AREA. AN ASTERISK NEXT TO THE PLT OR MPV PARAMETER MAY INDICATE THE PRESENCE OF AN ABNORMAL QUANTITY OF DEBRIS. "MEASURAND" FLAGGING MESSAGES OCCUR WHEN A SAMPLE EXHIBITS ANY REPORTABLE ABNORMALITIES, AS DETECTED BY THE SYSTEM. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE CELL-DYN EMERALD OPERATIONS MANUAL CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE CUSTOMER EVENT DETAILS AND THE CURRENT EVALUATION, NO PRODUCT MALFUNCTION WAS IDENTIFIED WITH THE CELL-DYN EMERALD INSTRUMENT. CORRECTION: THE INITIAL MDR REPORT DOCUMENTS: THE CUSTOMER REPORTS A LOW HEMOGLOBIN RESULT OF 5.0 K/UL ; THE CORRECT TEXT SHOULD READ: THE CUSTOMER REPORTS A LOW PLATELET RESULT OF 5.0 K/UL.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS A LOW HEMOGLOBIN RESULT OF 5.0 K/UL GENERATED FOR ONE PATIENT ON THE CELL- DYN EMERALD ANALYZER. THE PATIENT WAS SENT TO THE EMERGENCY ROOM WHERE A BLOOD SAMPLE TAKEN THERE GENERATED A RESULT OF 112 K/UL. THE CUSTOMER STATES THAT PREVENTIVE MAINTENANCE WAS PERFORMED BY AN ABBOTT FIELD SERVICE ENGINEER (FSE) THE DAY BEFORE AND THAT CONTROLS HAD BEEN WITHIN SPECIFICATIONS EARLIER IN THE DAY. THE CUSTOMER STATES THAT THE ANALYZER CANNOT BE USED AND THAT THE OFFICE PHYSICIAN IS DEMANDING THAT THE FSE RETURN TO RESOLVE THE ISSUE. THERE IS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3034 CELL-DYN EMERALD GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 RINSING HEAD PN: (B)(4)| RINSING HEAD PN: (B)(4)