BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 1863308 · Received October 9, 2010

    Report

    Report Number
    2122870-2010-00610
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    September 9, 2010
    Report Date
    October 8, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A 13X100MM GOLD TOP SERUM TUBE WITH A GEL SEPARATOR. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT. THE SYSTEM CHECKS PERFORMED ON (B)(6) 2010 AND (B)(6) 2010 FAILED WITH HIGH %CVS. SERVICE WAS DISPATCHED ON (B)(6) 2010. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE ASPIRATE PROBES AND PERFORMED ALL NECESSARY ALIGNMENT. THE FSE PERFORMED A SYSTEM CHECK AND QC. ALL RESULTS WERE WITHIN THE SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY ELEVATED TESTOSTERONE RESULT ABOVE THE NORMAL REFERENCE RANGE GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON AN ALTERNATE METHODOLOGY PRODUCED A RESULT WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION, OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR