BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM, SINGLE SYSTEM SG

    MDR report key: 2314054 · Received October 28, 2011

    Report

    Report Number
    2122870-2011-05008
    Event Type
    Malfunction
    Date Received
    October 28, 2011
    Date of Event
    September 28, 2011
    Report Date
    September 29, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT DEMOGRAPHIC AND DIAGNOSTIC INFORMATION WAS NOT SUPPLIED. NO SAMPLE COLLECTION AND CENTRIFUGATION DATA WAS PROVIDED. PER CUSTOMER COMPLAINT RECORD, QC RECOVERY WAS CONFIRMED AS PASSING. SYSTEM CHECKS WERE PERFORMED ON (B)(4) 2011 WITH ALL PASSING PARAMETERS. SAMPLES ARE BEING SENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR ADDITIONAL TESTING. CPLS TESTING RESULTS HAVE NOT BEEN RECEIVED TO DATE. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND PERFORMED VERIFICATION HARDWARE. NO ROOT CAUSE FOR THIS EVENT HAS BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) OF OBTAINING REACTIVE HEPATITIS B SURFACE ANTIGEN (HBSAG) RESULTS FROM ACCESS 2 IMMUNOASSAY SYSTEM FOR FIVE (5) PATIENT SAMPLES. THE CUSTOMER USED ACCESS HBSAG REAGENT (CATALOG NUMBER A24291) LOT 192336. REPEAT TESTING PRODUCED NON-REACTIVE INTERPRETATION. THE REACTIVE HBSAG RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER STATED THERE WAS NO DEATH OR 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, SINGLE SYSTEM SG ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1