BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2120888 · Received June 12, 2011

    Report

    Report Number
    2122870-2011-01855
    Event Type
    Malfunction
    Date Received
    June 12, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE AND PATIENT INFORMATION WAS NOT PROVIDED. QC LEVEL 1 AND 3 RESULTS IN IND FLAGS AFTER THE PATIENT RESULT WAS RUN TWICE. NO SAMPLE COLLECTION OR CENTRIFUGATION DATA WAS SUPPLIED BY THE CUSTOMER. HOTLINE WAS ABLE TO LOCATE A MISLOADED ACCUTNI REAGENT PACK. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. USE ERROR IS THE ROOT CAUSE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO RECEIVING AN INDETERMINATE (IND) FLAGS ON ONE PATIENT'S ACCUTNI RESULT AND QC RESULTS WHICH WERE GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY; THEREFORE PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT. THE CUSTOMER STATED THAT THE IND FLAG OCCURRED AFTER A TECHNICIAN CHANGED THE REAGENT PACK. 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