BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 1961966 · Received January 15, 2011

    Report

    Report Number
    2122870-2011-00062
    Event Type
    Malfunction
    Date Received
    January 15, 2011
    Date of Event
    December 18, 2010
    Report Date
    December 18, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE TROUBLESHOOTING WITH BCI HOTLINE, IT WAS DISCOVERED THAT THE REAGENT PACK WAS MISLOADED AND THERE WAS NO REAGENT PACK PRESENT IN THE DESIGNATED SLOT ON THE REAGENT STORAGE CAROUSEL. BCI CUSTOMER TECHNICAL SUPPORT (CTS) GAVE THE CUSTOMER INSTRUCTIONS FOR REMOVING THE MIS-LOADED PACK AND VERIFYING THE ONBOARD REAGENT INVENTORY. USER ERROR IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO NO VALUE IND* FLAGGED TROPONIN (ACCUTNI) RESULTS GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR QC AND SEVERAL PATIENTS. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. *IND = INDETERMINATE. THE RESULT IS AT THE LOW END OF THE ANALYTE CONCENTRATION CURVE.

    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