BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4378016 · Received January 2, 2015

    Report

    Report Number
    1061932-2015-00003
    Event Type
    Malfunction
    Date Received
    January 2, 2015
    Date of Event
    December 3, 2014
    Report Date
    December 4, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K120771
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE INFORMATION REGARDING WEIGHT OF THE PATIENT. ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND DID NOT IDENTIFY ANY INSTRUMENT DEFICIENCIES. THIS MDR IS RELATED TO MDR 1061932-2015-00004 FOR A SIMILAR EVENT WITH THE SECOND SAMPLE FROM THE SAME PATIENT TESTED ON A DIFFERENT DATE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL TEST RESULTS, WITHOUT INSTRUMENT GENERATED MESSAGES, WAS GENERATED WHEN USING THE UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM. THERE WERE TWO SAMPLES FROM THE SAME PATIENT, ONE COLLECTED AND TESTED ON (B)(6) 2014 AND THE OTHER SAMPLE WAS COLLECTED AND TESTED ON (B)(6) 2014. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THE ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. NOTE: THIS MDR IS FOR THE EVENT OCCURRING ON (B)(6) 2014. MDR 1061932-2015-00004 WAS FILED FOR THE EVENT OCCURRING ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309 UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR