BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM (CRATED)

    MDR report key: 1884376 · Received October 27, 2010

    Report

    Report Number
    2122870-2010-00673
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS SERUM THAT WAS CENTRIFUGED FOR 10 MINUTES AT 3050G. SAMPLE APPEARANCE WAS CLEAR AND WAS ASPIRATED FROM THE PRIMARY COLLECTION TUBE FOR ANALYSIS. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THIS EVENT. THERE WERE NO FLAGS ASSOCIATED WITH THE ERRONEOUS RESULT AND THE SYSTEM CHECKS HAVE BEEN MEETING SPECIFICATIONS. IT IS NOT INDICATED THAT SERVICE WAS DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ELEVATED TROPONIN (ACCUTNI) RESULT OF 0.58NG/ML GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM WHICH WAS QUESTIONED BY THE PHYSICIAN. UPON REPEAT TESTING THE RESULT WAS 0.01NG/ML WHICH WAS IN THE NORMAL REFERENCE RANGE. 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 (CRATED) DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1