BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 855920 · Received September 27, 2006

    Report

    Report Number
    2122870-2006-00200
    Event Type
    Other
    Date Received
    September 27, 2006
    Date of Event
    August 31, 2006
    Report Date
    September 27, 2006
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. SYSTEM CHECK PERFORMED IN 2006, PRIOR TO THE EVENT, PASSED. SYSTEM CHECK RAN TWO DAYS LATER, AT 09:30, AFTER THE INITIAL ERRONEOUS RESULT WAS OBTAINED, WAS WITHIN SPECIFICATIONS. SAMPLES ARE COLLECTED IN SERUM SEPARATOR TUBES. NO OTHER RESULTS OR ASSAY WERE IN QUESTION AT THIS TIME AND CUSTOMER STATED THAT THEY BELIEVE THIS EVENT IS ISOLATED TO ONE PT SAMPLE. CUSTOMER DECLINED SERVICE AS INSTRUMENT IS PERFORMING AS EXPECTED. ALTHOUGH CUSTOMER SUSPECTS THAT PRE-ANALYTICAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED IN THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING ERRONEOUS DIGOXIN (DIG) RESULTS THAT WERE GENERATED BY THE ACCESS 2 INSTRUMENT. THE INITIAL DIG RESULT WAS 2.93NG/ML. THE CUSTOMER RE-TESTED THE ORIGINAL SAMPLE FOR DIG ON THE SAME DAY AND OBTAINED LOWER RESULTS (1.74NG/ML, 1.29NG/ML, AND 1,57NG/ML). A FRESH SAMPLE (SERUM AND PLASMA) WAS COLLECTED FROM THE PT ON THE NEXT DAY AND TESTED FOR DIG. THE PLASMA RESULTS WERE: 2.1NG/ML, 2.9NG/ML AND 3.1NG/DML. THE SERUM RESULTS WERE: 3.4NG/ML, 2.4NG/ML AND 3.2NG/ML. THE CUSTOMER INDICATED THAT THE ERRONEOUS DIG RESULTS WERE NOT REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT THAT CAN BE ATTRIBUTED TO 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 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA