BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1971282 · Received January 26, 2011

    Report

    Report Number
    2122870-2011-00146
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 28, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH SAMPLES WERE LIHEPARIN PLASMAS AND WERE COLLECTED AT THE SAME TIME BY THE RESPIRATORY DEPARTMENT. THE COLLECTION TUBES WERE FILLED TO THE PROPER VOLUME AND THERE WAS NO VISIBLE FIBRIN. PER THE CUSTOMER, THE QC IS ANALYZED DAILY AND WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THIS EVENT. A SYSTEM CHECK WAS PERFORMED ON (B)(4) 2010 AND MET SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING REPRODUCIBLE MYOGLOBIN RESULTS ABOVE THE NORMAL REFERENCE RANGE FOR ONE PATIENT'S SAMPLE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, A SUBSEQUENT SAMPLE RESULTED WITHIN THE NORMAL REFERENCE RANGE AND WAS ALSO REPRODUCIBLE. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1