BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 2 ANALYZER

    MDR report key: 3833912 · Received May 27, 2014

    Report

    Report Number
    1061932-2014-01191
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND DETERMINED THE HEMOGLOBIN (HGB) LAMP, PREAMP AND LENSES REQUIRED REPLACEMENT. THE FSE REPLACED ALL PARTS RESOLVING THE UNSTABLE HGB VOLTAGE AND INCOMPLETE HGB RESULTS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INCOMPLETE HEMOGLOBIN (HGB) RESULTS ON PATIENT SAMPLES WHEN USING THE COULTER ACT DIFF 2 ANALYZER. THE CUSTOMER ALSO REPORTED THE HGB VOLTAGE WAS NOT STABLE. THE CUSTOMER STATED ALL PATIENT SAMPLES WERE CYCLED AND REPORTED FROM THE BACKUP ANALYZER DURING THE EVENT. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310713 COULTER ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1