BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1932246 · Received December 17, 2010

    Report

    Report Number
    2122870-2010-00903
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION IS NOT AVAILABLE. ALL THREE LEVELS OF TSH QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR AND POST THE EVENT. ON (B)(6) 2010, THE CUSTOMER PERFORMED ROUTINE SYSTEM CHECK; BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. CUSTOMER TECHNICAL SUPPORT OFFERED SERVICE VISIT; HOWEVER, THE CUSTOMER DECLINED THE SERVICE VISIT. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS ELEVATED TSH RESULT FOR ONE PATIENT GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER THE ORIGINAL SAMPLE WAS REPEATED ON THE SAME UNIT AND LOWER RESULT WAS OBTAINED. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO 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 JJE BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1