BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1984368 · Received February 10, 2011

    Report

    Report Number
    2122870-2011-00379
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JLB
    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

    THE SAMPLE IS PLASMA FROM A LI HEPARIN TUBE. THE CUSTOMER PERFORMED SEVERAL DILUTIONS THAT WERE NOT LINEAR. 1:5 = 82 NG/ML, 1:10 = 82 NG/ML, 1:20 = 76 NG/ML, 1:40 = 49.2 NG/ML. PER THE CUSTOMER, QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE ERRONEOUS RESULTS. SERVICE WAS OFFERED, BUT THE CUSTOMER DECLINED AS THE CUSTOMER IS NOT QUESTIONING ANY OTHER PATIENT RESULTS OR THE INSTRUMENT'S PERFORMANCE. NO ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING REPRODUCIBLE CREATININE KINASE - MB (CK-MB) RESULTS ABOVE THE NORMAL REFERENCE RANGE FOR ONE PATIENT'S SAMPLE THAT WERE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN AS THIS DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JLB BECKMAN COULTER INC. ACCESS® 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1