BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2330950 · Received November 10, 2011

    Report

    Report Number
    2122870-2011-05270
    Event Type
    Malfunction
    Date Received
    November 10, 2011
    Date of Event
    October 6, 2011
    Report Date
    October 10, 2011
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE DETAILS WERE PROVIDED. PER THE CUSTOMER COMPLAINT RECORDS, THE S5 VALUE ON THE CUSTOMER'S VITAMIN B12 CALIBRATOR WAS SCANNED IN AS 5513PG/ML, WHEN IT SHOULD HAVE BEEN 1513PG/ML. THE CALIBRATION PASSED AND QC WAS WITHIN ESTABLISHED RANGES. THIS INCORRECT VALUE WAS NOTICED ON (B)(4) 2011 BY THE CUSTOMER. THE B12 S5 CALIBRATOR VALUE WAS CORRECTED AND RECALIBRATED. AVAILABLE SAMPLES WERE THEN REPEATED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THERE IS NO DEFINITIVE ROOT CAUSE FOR THIS EVENT TO DATE. THIS REPORT IS RELATED TO THE FOLLOWING MDRS THAT ARE BEING REPORTED FOR THE SIMILAR EVENTS THAT OCCURRED AT THIS CUSTOMER SITE: 212870-2011-05273, 212870-2011-05274, 212870-2011-05275, 212870-2011-05276, 212870-2011-05277.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING AN ERRONEOUSLY ELEVATED VITAMIN B12 RESULT ABOVE THE NORMAL REFERENCE RANGE ON ONE (1) PATIENT'S SAMPLE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE SAMPLE WAS REPEATED AND RECOVERED WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. THE AFFECT TO PATIENT, IF ANY, IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1