BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2073401 · Received May 1, 2011

    Report

    Report Number
    2122870-2011-01214
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WAS NOT BEEN SUPPLIED. PER CUSTOMER, THEY BELIEVE THAT THE ORIGINAL ELEVATED DILUTION RESULTS WERE DUE TO TECHNICIAN ERROR. QC INFORMATION WAS NOT SUPPLIED. A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2011 AND PASSED WITHIN INSTRUMENT SPECIFICATIONS. SERVICE WAS NOT REQUESTED FOR THIS EVENT AS THE CUSTOMER WAS NOT QUESTIONING INSTRUMENT PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING HIGHER THAN EXPECTED TROPONIN (ACCUTNI) DILUTION RESULTS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT. SUBSEQUENT DILUTION TESTING PRODUCED LOWER RESULTS THAT WERE REPRODUCIBLE. 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 SYNCHRON® ACCESS® CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1