BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2094029 · Received May 18, 2011

    Report

    Report Number
    2122870-2011-01365
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. SYSTEM CHECKS PERFORMED ON (B)(6) 2011 MET SPECIFICATIONS. REAGENT INVENTORIES FROM BOTH INSTRUMENTS RULE OUT A SHARED PACK FOR THIS EVENT. A SERVICE CALL WAS SET UP AND LATER CANCELED. NO CLEAR ROOT CAUSE COULD BE DETERMINED WITH THE DATA SUPPLIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI), REGARDING PROGESTERONE RESULTS OF 0NG/ML GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM ON UNKNOWN NUMBER OF PATIENTS. THE CUSTOMER STATED UPON REPEAT ON A DIFFERENT INSTRUMENT "ACTUAL RESULTS" WERE OBTAINED. THE RESULTS GENERATED BY THE DIFFERENT INSTRUMENT WERE NOT SUPPLIED BY THE CUSTOMER. THE RESULTS WERE NOT REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH 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 IMMUNOASSAY SYSTEM, REFURBISHED N/A

    Patients

    Seq Age Sex Outcome Treatment
    1