BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 2024360 · Received March 18, 2011

    Report

    Report Number
    2122870-2011-00732
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    January 5, 2008
    Report Date
    February 29, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN TUBE, AND CENTRIFUGED AT 2000 G FOR 10 MINUTES. SYSTEM CHECK PERFORMED ON (B)(4) 2007 PRODUCED RESULTS WITHIN THE SPECIFICATIONS. IT IS UNCERTAIN IF SERVICE WAS DISPATCHED FOR THIS EVENT AS THIS IS ISOLATED TO ONE PATIENT'S SAMPLES. THE SAMPLES WERE RECEIVED AND TESTED AT BCI. THE RESULTS OF INTERFERENCE TESTING CONFIRMED THE EXISTENCE OF A PATIENT SOURCE INTERFERENT FOR THE SAMPLES RECEIVED FROM THE CUSTOMER. THIS INTERFERING COMPOUND CAUSES REPRODUCIBLE FALSE POSITIVE RESULTS, BUT IS DISTINCT FROM HETEROPHILE ANTIBODIES. SIMILAR TO HETEROPHILE ANTIBODIES, THE RESULTS DO NOT CORRELATE WITH THE CLINICAL STATUS OF THE PATIENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS WITHIN THE DATE RANGE OF (B)(4) 2010 - (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR FIFTEEN (15) SAMPLES OF A PATIENT. THE RESULTS WERE REPORTED OUT OF THE LABORATORY, AND WERE DISCORDANT TO TWO OTHER METHODS. THE EVENT OCCURRED BETWEEN (B)(6) 2008 AND (B)(6) 2008. THE RESULTS OF THE OTHER FOURTEEN (14) SAMPLES ARE REPORTED IN MEDWATCH # 2122870-2011-00729 TO 2122870-2011-00743. 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 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR