BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1860886 · Received October 7, 2010

    Report

    Report Number
    2122870-2010-00598
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 5, 2010
    Report Date
    October 7, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DIAGNOSTIC COPY TO DISK DATA SHOWED THE ERRONEOUSLY LOW ACCUTNI RESULT OCCURRED ON A REAGENT PACK THAT WAS SHARED BETWEEN TWO INSTRUMENTS. QC RUN ON THE SHARED REAGENT PACK PRIOR TO THE ERRONEOUS RESULT WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. THREE LEVELS OF QC RUN ON THE SHARED REAGENT PACK AFTER THE ERRONEOUS RESULT WERE ALL 0 NG/ML. A SYSTEM CHECK PERFORMED AFTER THE ERRONEOUS RESULTS MET SPECIFICATIONS. THE CUSTOMER WAS INFORMED OF OTHER POTENTIAL ERRONEOUS RESULTS MAY HAVE BEEN PRODUCED FROM REAGENT PACK WHICH WAS SHARED. CUSTOMER STATED ONLY ONE PATIENT'S ERRONEOUSLY LOW ACCUTNI RESULT WAS IN QUESTION. SERVICE WAS OFFERED AND DECLINED BECAUSE THE CUSTOMER STATED THE ERRONEOUS RESULT WAS ISOLATED TO ONE PATIENT SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING AN ERRONEOUSLY LOW TROPONIN (ACCUTNI) RESULT, IN THE NORMAL REFERENCE, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LAB AND WAS QUESTIONED BY THE PHYSICIAN. REPEAT TESTING OF THE ORIGINAL SAMPLE AND SUBSEQUENT SAMPLES RESULTED ABOVE THE AMI CUTOFF WHICH BETTER FIT THE PATIENT'S CLINICAL PICTURE. 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 MMI BECKMAN COULTER INC. ACCESS® 2 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1