BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT 5DIFF CAP PIERCE (CP)

    MDR report key: 3840031 · Received May 30, 2014

    Report

    Report Number
    1061932-2014-01226
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 29, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND REPLACED THE HEMOGLOBIN (HGB) REAGENT PICK-UP STRAW AND STOPPER, REAGENT SYRINGE, SYRINGE DRIVE MOTOR ASSEMBLY, AND 5-VALVE WASTE MANIFOLD. THE FSE ALSO NOTED A LOOSE SAMPLE CARRIAGE ASSEMBLY AND PROCEEDED TO TIGHTEN THE LOOSE CARRIAGE ASSEMBLY. THE FSE THEN CLEANED AND LUBRICATED THE CARRIAGE GUIDE RODS, AND CHECKED AND ADJUSTED THE CALIBRATION FACTORS. THE FSE PERFORMED START-UP, REPRODUCIBILITY, CONTROLS, AND OBTAINED PASSING RESULTS WHICH WERE WITHIN ESTABLISHED RANGES AND WITHOUT ANY ERRORS. ALTHOUGH A SPECIFIC MALFUNCTION COULD NOT BE IDENTIFIED FOR THIS EVENT, THE ISSUE WAS RESOLVE THROUGH SERVICE ACTIONS PERFORMED BY THE FSE. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 1061932-2014-01226; 1061932-2014-01227.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING LOW HEMOGLOBIN (HGB) RESULTS FOR MULTIPLE PATIENT SAMPLES RAN ON THE COULTER ACT 5DIFF CAP PIERCE (CP), OVER TWO (2) DIFFERENT DAYS. THE CUSTOMER PROVIDED RESULTS FOR FIVE (5) PATIENTS INVOLVED IN THE TWO (2) EVENTS. THIS REPORT REFERENCES THE EVENT WHICH OCCURRED ON (B)(6) 2014; PLEASE REFER TO MDR REPORT 1061932-2014-01227 FOR A REPORT OF THE EVENT WHICH OCCURRED ON (B)(6) 2014. 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. THE CUSTOMER SENT THE SAMPLES TO THE HOSPITAL FOR A RERUN AND OBTAINED HIGHER HGB RESULTS. THE CUSTOMER DID NOT PROVIDE ACTUAL INSTRUMENT PRINTOUTS AND IT IS UNKNOWN IF INSTRUMENT FLAGS WERE GENERATED FOR THIS EVENT; THE CUSTOMER PROVIDED ONLY LABORATORY INSTRUMENTATION SYSTEM (LIS) PRINTOUTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318892 COULTER ACT 5DIFF CAP PIERCE (CP) COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR