BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1930952 · Received December 17, 2010

    Report

    Report Number
    2122870-2010-00948
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO RUNNING PATIENT SAMPLE, THE CUSTOMER REPORTED SMELLING AN ELECTRICAL BURNING SMELL. THE CUSTOMER WAS UNABLE TO DETERMINE WHERE THE SMELL WAS ORIGINATING. NO SMOKE OR FLAMES WERE REPORTED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2010. THE FSE INSPECTED THAT THE PRESSURE BOARD HAD SHORTED OUT AND WAS REPLACED. THE FSE ALSO REPLACED THE PERI-TUBING, INCUBATOR BELT AND CLIPS. A HIGH SENSITIVITY (HS) TEST AND QC WAS PERFORMED AND ALL TESTING PASSED WITHIN PUBLISHED SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, NO DEFINITIVE ROOT CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY ELEVATED RESULTS FOR TROPONIN (ACCUTNI) RESULTS ABOVE THE AMI-CUTOFF ON ONE PATIENT'S SAMPLE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER ALSO OBTAINED ERRONEOUSLY ELEVATED CREATININE KINASE - MB (CKMB) AND MYOGLOBIN RESULTS ABOVE THE NORMAL REFERENCE RANG EON THE SAME PATIENT'S SAMPLE. THE SAMPLE WAS SENT TO AN ALTERNATE LAB WHICH RECOVERED "NORMAL" RESULTS FOR ALL THREE ASSAYS. NO ERRONEOUS RESULTS WERE 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 WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1