BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON ® CX DELTA CLINICAL SYSTEMS

    MDR report key: 2151878 · Received July 6, 2011

    Report

    Report Number
    2050012-2011-01177
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGX
    PMA / PMN Number
    K071280
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED. CUSTOMER WAS PROVIDED WITH NEW REAGENT. THIS REPORT IS BEING RESUBMITTED. THE INITIAL REPORT (2050012-2011-01177) WAS SUBMITTED ON (B)(4) 2011 HOWEVER, IN THE E-REPORT UNDER THE MFR REPORT NUMBER 2122870-2011-01177 WAS ENTERED INADVERTENTLY, WHICH CAUSED A DUPLICATION ERROR TO OCCUR ON THE CORRECT REPORT NUMBER 2122870-2011-01177 WHICH WAS INITIALLY SUBMITTED ON (B)(4) 2011. PER DISCUSSION WITH CDRH EMDR, REPORT 2122870-2011-01177 NEEDED TO BE REMOVED FROM THE ESG SYSTEM PRIOR TO OUR RESUBMISSION OF THE CORRECT REPORTS (2050012-2011-01177 AND 2122870-2011-01177). THE REPORT WAS REMOVED PER CDRH EMDR EMAIL ON (B)(4) 2011, HENCE THE RESUBMISSION OF CORRECT REPORTS ON (B)(4) 2011.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THE BOTTOM OF THE CREATININE BOTTLE IS CHAPPED. THE CUSTOMER DID NOT REPORT ANY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON ® CX DELTA CLINICAL SYSTEMS CREATININE TEST SYSTEM CGX BECKMAN COULTER INC. N/A Z010001

    Patients

    Seq Age Sex Outcome Treatment
    1