BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2297293 · Received October 15, 2011

    Report

    Report Number
    2122870-2011-04415
    Event Type
    Malfunction
    Date Received
    October 15, 2011
    Date of Event
    September 14, 2011
    Report Date
    September 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLES WERE COLLECTED IN A 13 X 100 MM GREINER LIHEP PLASMA TUBE AND CENTRIFUGED FOR 7 MINUTES AT 4200 G AT ROOM TEMPERATURE. THE CUSTOMER NOTED THAT THE SAMPLES WERE ORIGINALLY ANALYZED FROM THE PRIMARY TUBES. VISUAL INSPECTION OF THE SAMPLES SHOWED THAT SAMPLES APPEARED CLEAR AND FULL DRAWS. THE CUSTOMER DID NOT SUPPLY QUALITY CONTROL (QC) AND SYSTEM INFORMATION. SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT TO DATE. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-04350, 2122870-2011-04415.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING A HIGHER THAN EXPECTED TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE FOR TWO (2) PATIENTS, GENERATED BY A UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM, USED IN CONJUNCTION WITH ACCESS ACCUTNI REAGENT (LOT 112431). THESE RESULTS WERE REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE FOR BOTH PATIENTS. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. DXI 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1