BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 1832369 · Received September 13, 2010

    Report

    Report Number
    2122870-2010-00532
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 12, 2010
    Report Date
    September 10, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WAS NOT SUPPLIED. QC RESULTS DURING THE EVENT WERE ALSO REPORTED AS NO VALUE WITH IND FLAGS. WHILE TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS FOUND THAT THERE WAS NO REAGENT PACK IN THE DESIGNATED SLOT ON THE REAGENT STORAGE CAROUSEL. SERVICE WAS NOT DISPATCHED AS THE ISSUE WAS RESOLVED BY TROUBLESHOOTING WITH CTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO NO VALUE TROPONIN (ACCUTNI) RESULTS WITH IND FLAGS GENERATED ON ACCESS 2 IMMUNOASSAY SYSTEM FOR SEVERAL PATIENT SAMPLES AND QC. (IND MEANS INDETERMINATE. THE RESULT IS AT THE LOW END OF THE ANALYTE CONCENTRATION CURVE.) THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1