BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON CX7 DELTA

    MDR report key: 154857 · Received March 2, 1998

    Report

    Report Number
    2050012-1998-00001
    Event Type
    Other
    Date Received
    March 2, 1998
    Date of Event
    January 2, 1998
    Report Date
    February 19, 1998
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Product Code
    JJC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FORWARDED THE ATTACHED MEDWATCH FORM (NO. 3500) REGARDING THE PERFORMANCE OF THIS PRODUCT. WHILE CO BELIEVES THAT THE MFR CRITERIA FOR SUBMISSION OF AN MDR HAS NOT BEEN MET. CO IS SUBMITTING THIS MDR BASED ON THE NUMBER OF SAMPLES AND THE DURATION OF THE EVENT INDICATED ON THE USER'S REPORT. THE USER CLAIMS THAT THIS INSTRUMENT PRODUCED INCORRECT RESULTS THAT MAY HAVE BEEN USED IN MAKING DECISIONS REGARDING TREATMENT AND/OR DIAGNOSIS. THE MFR'S FIELD SUPPORT AND SALES PERSONNEL HAVE BEEN IN CONTACT WITH THE USER AND HAVE MADE MULTIPLE REQUESTS FOR MORE SPECIFIC INFO ABOUT THE ANALYTES INVOLVED, THE NATURE OF THE CLAIMED ERRORS, AND THE DIAGNOSIS OR TREATMENT THAT WAS BASED ON INCORRECT INFO. NO ADD'L INFO HAS BEEN REC'D THE USER INDICATES THAT SERUM CLOST MAY HAVE CONTRIBUTED TO THE ALLEGED ERRORS. THE PRODUCT'S LABELING STATES THAT 'CLOT FREE' SERUM MUST BE USED AND THAT CLOTS OR FIBRIN MAY AFFECT PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX7 DELTA CLINICAL CHEMISTRY ANALYZER JJC BECKMAN INSTRUMENTS, INC. CX7 DELTA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other