BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT 5DIFF CAP PIERCE (CP)

    MDR report key: 2951149 · Received February 8, 2013

    Report

    Report Number
    1061932-2013-00161
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 18, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: DIFF SYRINGE ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY HIGH MONOCYTES (MO%) RESULTS FOR THREE PATIENTS WHICH OCCURRED OVER 3 DIFFERENT DAYS INVOLVING THE COULTER ACT 5DIFF CAP PIERCE (CP). THE CUSTOMER INDICATED THAT THE ERRONEOUS RESULTS OCCURRED WHEN THE INSTRUMENT WAS USED AFTER IDLING FOR A WHILE. THIS REPORT IS FOR THE EVENT WHICH OCCURRED ON (B)(6) 2013. PLEASE SEE MEDWATCH #1061932-2013-00159 AND #1061932-2013-00160 FOR THE EVENTS WHICH OCCURRED ON THE OTHER 3 DAYS. THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY LOW MONOCYTES RESULTS FOR A PATIENT ON (B)(6) 2013. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY THE NEXT DAY AND RESULTS WHICH WERE CONSIDERED CORRECT WERE OBTAINED FROM AN ALTERNATE ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. PER THE CUSTOMER'S LABORATORY PROTOCOL, ALL QUESTIONABLE RESULTS ARE REPEATED AND FLAGGED SAMPLES ARE SENT TO A REFERENCE LABORATORY FOR CONFIRMATION; THE LABORATORY DOES NOT MAKE MANUAL SMEARS. DATA REVIEW OF THE PRINTOUTS PROVIDED BY THE CUSTOMER INDICATED THAT NEUTROPHIL (NE%) RECOVERED LOWER WITHOUT INSTRUMENT GENERATED DIFF PLOT FLAGS. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REBUILT THE DIFF SYRINGE ASSEMBLY. THE DIFF FIX REAGENT LINE WAS CLEANED AND THE DIFF FIX REAGENT WAS REPLACED AS A PREVENTATIVE MAINTENANCE. FAILURE MODE WAS DETERMINED TO BE THE DIFF SYRINGE ASSEMBLY AND ISSUE WAS RESOLVED FOLLOWING SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53585 COULTER® ACT 5DIFF CAP PIERCE (CP) COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR