BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 1832578 · Received September 13, 2010

    Report

    Report Number
    2122870-2010-00520
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 15, 2010
    Report Date
    September 13, 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
    JO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED AT MULTIPLE SATELLITE SITES, AND CENTRIFUGED AT 4000 RPM FOR 4 MINUTES AT ROOM TEMPERATURE. QC AND SYSTEM CHECK INFORMATION WAS NOT SUPPLIED. BCI CUSTOMER PRODUCT LINE SUPPORT (CPLS) RECEIVED AND TESTED PATIENT SAMPLES. CPLS NOTED THAT THE SAMPLE TYPES WERE EDTA. PER BCI LABELING, SERUM AND PLASMA (HEPARIN) ARE THE RECOMMENDED SAMPLES. USER ERROR IS ONE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ELEVATED VITAMIN B12 RESULTS ABOVE THE NORMAL REFERENCE RANGE GENERATED ON ACCESS 2 IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENTS' SAMPLES THAT WERE DISCORDANT TO SEVERAL ALTERNATE METHODS THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF DEATH, INJURY, 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 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1