BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 2110562 · Received June 1, 2011

    Report

    Report Number
    2122870-2011-01637
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 4, 2011
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN GREINER VACUETTE 7ML TUBES, AND WERE SPUN FOR 10 MINUTES AT 3750GS AT ROOM TEMPERATURE. QC RUN IMMEDIATELY AFTER THE EVENT RECOVERED OUTSIDE THE ESTABLISHED RANGES. REPEATED QC CONTINUED TO FAIL. ACCUTNI WAS RECALIBRATED, AND QC THEN RECOVERED WITHIN THE ESTABLISHED RANGES. SYSTEM CHECK DATA, FROM BEFORE AND AFTER THE EVENT, WAS WITHIN THE SPECIFICATIONS. SERVICE WAS DISPATCHED TO VERIFY THE SYSTEM. HIGH SENSITIVITY SYSTEM CHECK WAS PERFORMED TWICE, RECOVERING WITHIN BECKMAN SPECIFICATIONS BOTH TIMES. PRECISION RUN ALSO WAS PERFORMED, PASSING WITHIN BECKMAN SPECIFICATIONS. ROOT CAUSE FOR THIS EVENT WAS UNDETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PATIENTS. THE RESULTS WERE REPORTED OUT OF THE LABORATORY, BUT THE DOCTOR DID NOT BELIEVE THE RESULTS AND CONTACTED THE CUSTOMER. SUBSEQUENT TESTING AFTER RECALIBRATION PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE RESULTS ARE SHOWN. THE CUSTOMER STATED THERE WAS NO DEATH OR INJURY TO PATIENT REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED 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