BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 1951531 · Received January 6, 2011

    Report

    Report Number
    2122870-2010-00992
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI CUSTOMER TECHNICAL SUPPORT TROUBLESHOT THE EVENT WITH THE CUSTOMER AND IT WAS DETERMINED THAT THE RESULTS CAME FROM AN EMPTY REAGENT PACK IN WHICH THE INSTRUMENT'S REAGENT INVENTORY INDICATED SEVEN TESTS SHOULD HAVE BEEN REMAINING. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A DEFINITIVE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO ERRONEOUS BNP (B-TYPE NATRIURETIC PEPTIDE) RESULTS OF NO VALUE WITH IND FLAGS GENERATED BY ACCESS 2 IMMUNOASSAY CLINICAL SYSTEM FOR UNKNOWN NUMBER OF PATIENTS. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT REPORT EFFECT TO PATIENT OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1