BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1810479 · Received August 20, 2010

    Report

    Report Number
    2122870-2010-00459
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JLW
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS CENTRIFUGED FOR TEN MINUTES AT 3000RPM. QC WAS BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT. THE SAMPLE WAS SENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR TESTING AND THE PRESENCE OF A PATIENT SOURCE HETEROPHILE INTERFERENT WAS CONFIRMED WHICH IS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ELEVATED TSH RESULT OF 39.3 IU/ML GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. SUBSEQUENT TESTING ON AN ALTERNATE METHODOLOGY PRODUCED DISCORDANT RESULTS OF 0.04, '<0.01 IU/ML' IN A LOWER CLINICAL CATEGORY. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DID NOT REPORT ANY PATIENT INJURY REQUIRING MEDICAL INTERVENTION 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 SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JLW BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1