BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2079531 · Received May 6, 2011

    Report

    Report Number
    2122870-2011-01310
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS ONSITE TO REPAIR TO THIS INSTRUMENT ON (B)(4) 2011, BUT THE FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO DETERMINE A ROOT CAUSE INTO THE ISSUES BEING ADDRESSED ON THAT DATE. THE PATIENT SAMPLES WERE REPEATED TO ASSESS THE STATUS OF THE INSTRUMENT AFTER INSTRUMENT SERVICE WAS COMPLETED ON (B)(4) 2011. THE CUSTOMER NOTED THE PATIENT SAMPLES DID NOT CORRELATE BETWEEN THEIR TWO INSTRUMENTS AFTER SERVICE HAD BEEN ON SITE ON (B)(4) 2011. THE SAMPLE COLLECTION, CENTRIFUGATION AND STORAGE INFORMATION HAS NOT BEEN SUPPLIED TO DATE. QC HAD BEEN PERFORMING WITHIN THE ESTABLISHED RANGES. SERVICE WAS ON SITE ON (B)(4) 2011, AND A SYSTEM CHECK FAILED TO MEET INSTRUMENT SPECIFICATIONS. THE FSE EVALUATED THE INSTRUMENT HARDWARE AND DETERMINED THE INSTRUMENT REQUIRED A NEW ULTRASONIC TRANSDUCER. THE FSE REPLACED THE TRANSDUCER, AND VERIFIED HARDWARE PERFORMANCE AFTER SERVICE WAS COMPLETE. THE FSE COMPLETED A 50 REPLICATE PRECISION RUN USING WASH BUFFER. THE FSE ALSO PERFORMED A 20 REPLICATES PRECISION RUN OF LOW LEVEL ACCUTNI QC, AND ACCEPTABLE RESULTS WERE OBTAINED. ALTHOUGH SOME HARDWARE ISSUES WERE ADDRESSED BY THE FSE AT THE TIME OF SERVICE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT, ABOVE THE AMI CUTOFF, GENERATED BY UNICEL DXC 600I ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING ON THE SAME AND ON AN ALTERNATE INSTRUMENT PRODUCED LOWER RESULTS. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1