BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2060386 · Received April 15, 2011

    Report

    Report Number
    2122870-2011-00971
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    April 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES ARE COLLECTED INTO BD 7ML TUBES WHICH ARE CENTRIFUGED AT 3000 RPM. PER THE CUSTOMER QC DATA, ACCUTNI QC HAS BEEN WITHIN THE ESTABLISHED RANGES. SYSTEM CHECKS WERE PERFORMED ON (B)(4) 2008 AND ALL RESULTS MET ESTABLISHED SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 07/08/2008 FOR THIS EVENT. THE FSE PERFORMED TROUBLESHOOTING AND REPLACED AND REPAIRED MULTIPLE HARDWARE PARTS AND PERFORMED ALL THE NECESSARY ALIGNMENTS. THE FSE RAN A FULL SYSTEM CHECK AND A HIGH SENSITIVE SYSTEM CHECK AND ALL TESTS PASSED. ALTHOUGH THE FSE MADE HARDWARE REPAIRS TO THE SYSTEM IN QUESTION, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS WITHIN THE DATE RANGE OF (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ELEVATED TROPONIN (ACCUTNI) RESULTS FOR EIGHT (8) PATIENTS' SAMPLES, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE BOTH ABOVE AND BELOW THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. REPEAT TESTING RESULTED IN LOWER RESULTS. THIS EVENT OCCURRED ON (B)(6) 2008, AND (B)(6) 2008. THIS REPORTABLE EVENT CAPTURES THE ERRONEOUS ACCUTNI RESULTS THAT WERE GENERATED ON (B)(6) 2008. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. THIS REPORT IS RELATED TO MEDWATCH #2122870-2011-00970, 2122870-2011-00972, AND 2122870-2011-00973 THAT CAPTURES THE DIFFERENT DATES REPORTED FOR THIS SIMILAR EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1