BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1930955 · Received December 17, 2010

    Report

    Report Number
    2122870-2010-00947
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHA
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED NO ISSUE WITH QC UP TO THE DATE OF THE EVENT. THE CUSTOMER REPORTED THAT THE MOST RECENT SYSTEM CHECK WAS PASSING ALL PORTIONS. SERVICE WAS DISPATCHED, BUT CANCELLED BY THE CUSTOMER AS THEY OWN BIO-MEDICAL ENGINEER THAT WILL VERIFY THE SYSTEM. PER THE CUSTOMER, THE BIO-MEDICAL ENGINEER FOUND THE SAMPLE PROBE TO BE TOO HIGH AND THE SUBSTRATE WAS CONTAMINATED. THE CUSTOMER PERFORMED SUBSTRATE DECONTAMINATION AND MADE ADJUSTMENTS TO THE SAMPLE PROBE. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING FALSE POSITIVE BHCG (BETA - HUMAN CHORIONIC GONADOTROPIN) RESULTS ON APPROXIMATELY 5 -6 PATIENTS' SAMPLES GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT AND RECOVERED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1