BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2121805 · Received May 20, 2011

    Report

    Report Number
    2122870-2011-01400
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    July 13, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CFR
    PMA / PMN Number
    K060256
    Removal / Correction Number
    Z-0607-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE ISSUE WAS RESOLVED DURING THE INITIAL TROUBLESHOOTING VIA THE TELEPHONE. NO SAMPLE COLLECTION OR CENTRIFUGATION DATA WAS SUPPLIED BY THE CUSTOMER. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 TO (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS MEDWATCH IS RELATED TO THE ORIGINAL MDR 2122870-2010-00427, PATIENT NUMBER ONE. RELATED MDRS: 2122870-2011-01179, 01180, 01181, 01394, 01395, 01396, 01397, 01398, 01399.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED HIGHER THYROID-STIMULATING HORMONE (TSH) RESULTS ON ELEVEN PATIENTS' SAMPLES INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THIS REPORT REFERS TO PATIENT NUMBER ELEVEN. IT WAS DETERMINED THE CUSTOMER HAD INCORRECTLY LOADED A CREATINE KINASE-MB (CK-MB) REAGENT PACK IN PLACE OF THE TSH REAGENT PACK. THREE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THESE SAMPLES WERE RETESTED USING A TSH REAGENT PACK AND PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. IT IS UNKNOWN IF THE OTHER EIGHT PATIENTS' RESULTS WERE REPORTED OUT OF THE LABORATORY OR IF PATIENT TREATMENT WAS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM CFR BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS HYPERSENSITIVE HTSH