BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2132126 · Received June 17, 2011

    Report

    Report Number
    2122870-2011-01908
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 17, 2011
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION DEVICE AND CENTRIFUGE INFORMATION HAVE NOT BEEN SUPPLIED TO DATE. SYSTEM CHECK COMPLETED ON (B)(6) 2011 PASSED WITHIN INSTRUMENT SPECIFICATIONS. QC PERFORMED WITHIN THE CUSTOMER'S SPECIFICATIONS. SERVICE INFORMATION HAS NOT BEEN PROVIDED. THE SAMPLE WAS SENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR INVESTIGATIONAL TESTING. (B)(6) RESULT OBTAINED BY THE LAB ON THIS SAMPLE WAS CONFIRMED BY THE CPLS LAB. HETEROPHILE TESTING ON IGM AND IGG ELUTION FRACTIONS DID NOT DEMONSTRATE THE PRESENCE OF AN INTERFERING COMPOUND. CPLS DID NOT FIND EVIDENCE OF A DEFECTIVE REAGENT. A DEFINITIVE 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 (B)(6) HEPATITIS B ANTIBODY RESULTS THAT DID NOT FIT THE CLINICAL PICTURE FOR ONE PATIENT GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE INITIAL SAMPLE WAS RERUN ON THE SAME UNIT AND ON AN ALTERNATE METHOD. THE REPEAT RESULTS ON ACCESS TWO MATCHED THE INITIAL RUN RESULTS. THE ALTERNATE METHOD RESULT DID NOT MATCH THE (B)(6) HEPATITIS B ANTIBODY RESULTS OBTAINED ON THE ACCESS 2 IMMUNOASSAY ANALYZER. 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