BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2930496 · Received January 28, 2013

    Report

    Report Number
    2122870-2013-00047
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    December 29, 2012
    Report Date
    December 31, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ONE OF THREE REPORTS RELATED TO THREE EVENTS THAT OCCURRED ON TWO DAYS. THIS REPORT IS RELATED TO MDR# 2122870-2013-00048, MDR# 2122870-2013-00053.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM (DXC 600I) GENERATED A TROPONIN I (ACCUTNI) RESULT THAT WAS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF VALUE. THE RESULT WAS REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THE PHYSICIAN INITIATED TREATMENT BASED ON THE RESULT. THE SPECIFICS OF THE TREATMENT ARE UNKNOWN. THE PHYSICIAN QUESTIONED THE RESULT AFTER THE TREATMENT. CUSTOMER REPORTED THEY REPEATED THE SPECIMEN ON THEIR OTHER DXC 600I ANALYZER AND OBTAINED AN ACCUTNI RESULT BELOW THE AMI CUTOFF VALUE. CUSTOMER REPORTED THEY USED ACCUTNI REAGENT LOT 225168 WITH CALIBRATOR LOT 122817 IN CONJUNCTION WITH DXC 600I ANALYZER. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE TO EVALUATE THE INSTRUMENT. THE FSE FOUND AIR WAS ENTERING THE WASH PUMP DURING DISPENSE PROBE PRIMING CAUSING FOAMING. THE FSE REPLACED THE FLUIDICS MANIFOLD. THE FSE PERFORMED AN ACCUTNI PRECISION RUN, WHICH PASSED WITHIN SPECIFICATION. THE FSE PERFORMED A SYSTEM CHECK, WHICH PASSED WITH ALL PARAMETERS WITHIN SPECIFICATION. THE FSE VERIFIED QUALITY CONTROL WAS WITHIN THE CUSTOMER'S ESTABLISHED LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36453 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other