BEUDAMED
    FDA Adverse Event Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1914277 · Received December 3, 2010

    Report

    Report Number
    2122870-2010-00841
    Date Received
    December 3, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL THREE LEVELS OF ACCUTNI QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRE AND POST THE EVENT. ON (B)(6) 2010, A ROUTINE SYSTEM CHECK WAS PERFORMED AND FAILED THE WASH SPECIFICATION. THE CUSTOMER REPEATED THE SYSTEM CHECK WHICH PASSED WITHIN SPECIFICATION. CUSTOMER TECHNICAL SUPPORT (CTS) REQUESTED ANOTHER SYSTEM CHECK, AFTER CHANGING THE ASPIRATE PROBES AND VERIFYING PERI-PUMP TUBING, WHICH PASSED WELL WITHIN INSTRUMENT SPECIFICATIONS. SERVICE WAS NOT DISPATCHED, SINCE THE LIKELY ROOT CAUSE WAS DISCOVERED WHILE TROUBLESHOOTING WITH THE CTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ELEVATED ACCUTNL RESULTS WITHIN THE RISK STRATIFICATION RANGE FOR TWO PATIENTS GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE ORIGINAL SAMPLES WERE REPEATED AND LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE WERE OBTAINED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF 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 JJE BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1