BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2140232 · Received June 26, 2011

    Report

    Report Number
    2122870-2011-02035
    Event Type
    Malfunction
    Date Received
    June 26, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 26, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHA
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN A 10ML TUBE AND CENTRIFUGED FOR 10 MINUTES AT 3200 RPM. SAMPLE TYPE HAS NOT BEEN SUPPLIED TO DATE. BHCG QC HAS BEEN WITHIN CUSTOMER'S ESTABLISHED RANGES. SPECIFIC QC DATA HAS NOT BEEN SUPPLIED TO DATE. SYSTEM CHECKS HAVE BEEN PERFORMED ROUTINELY AND HAVE PASSED WITHIN INSTRUMENT SPECIFICATIONS. SPECIFIC SYSTEM CHECK DATA HAS NOT BEEN SUPPLIED TO DATE. CUSTOMER STATED THAT THERE WERE NO ERRORS POSTED TO EVENT LOG IN CONJUNCTION WITH THIS EVENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT WITH THE DATA PROVIDE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) THAT THE ACCESS 2 IMMUNOASSAY SYSTEM GENERATED HIGHER THAN EXPECTED BHCG RESULTS ABOVE THE NORMAL REFERENCE RANGE FOR ONE (1) PATIENT. THIS RESULT WAS REPORTED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN BECAUSE THE RESULT DID NOT MATCH THE CLINICAL PRESENTATION OF THE PATIENT. 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 DHA BECKMAN COULTER INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1