BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2073497 · Received May 2, 2011

    Report

    Report Number
    2122870-2011-01166
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN PST TUBE AND CENTRIFUGED AT 5060 RPM FOR 3 MINUTES. THE SAMPLE APPEARED NORMAL. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT. QC WAS OUT OF SPECIFICATIONS HIGH THE DAY OF THE EVENT AT 10:26 PM. A SYSTEM CHECK PERFORMED ON (B)(4) 2011 MET SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS ON SITE WORKING ON ANOTHER INSTRUMENT AND HELPED THE CUSTOMER ON THIS INSTRUMENT. THE FSE REMOVED GAUZE FROM THE INCUBATOR TRACK AND ANOTHER ONE THAT WAS CAUGHT IN THE CARD CAGE FAN. THE ASPIRATE PROBE IN POSITION 6 WAS BENT. THE FSE REPLACED THE ASPIRATE PROBES ALONG WITH THE SAMPLE PIPETTOR. THE FSE PERFORMED PREVENTIVE MAINTENANCE (PM); ALL VERIFICATION TESTING MET SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING A FALSELY ELEVATED TROPONIN (ACCUTNI) RESULT GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LAB. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE RESULT WAS QUESTIONED BY THE PHYSICIAN. REPEAT TESTING RESULTED WITHIN A LOWER CLINICAL CATEGORY THAT BETTER MATCHED THE PATIENT'S CLINICAL PICTURE. PATIENT RESULTS WERE NOT SUPPLIED.

    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 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization