BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 905815 · Received August 30, 2007

    Report

    Report Number
    2122870-2007-00204
    Event Type
    Other
    Date Received
    August 30, 2007
    Date of Event
    August 8, 2007
    Report Date
    August 30, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: QC PERFORMED ON THE DATE OF THE EVENT WAS WITHIN SPECIFICATIONS. SYSTEM CHECKS TWO TIMES IN 2007 WERE WITHIN SPECIFICATIONS. SAMPLE WAS DRAWN INTO A RED TOP SERUM TUBE AND CENTRIFUGED FOR 5 MINUTES (RPM INFORMATION WAS NOT PROVIDED). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER LAB ON SIX DAYS LATER. THE FSE TIGHTENED A LOOSE CONNECTOR ON THE SUBSTRATE BOTTLE. THE FSE PERFORMED SYSTEM CHECK AND LUMWASHSON/INC. THAT WERE WITHIN SPECIFICATIONS. THE FSE VERIFIED THE INSTRUMENT WAS OPERATING PER ESTABLISHED PROCEDURES. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED IN THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT FROM ONE (1) PATIENT SAMPLE THAT WAS GENERATED BY THE ACCESS 2 INSTRUMENT. THE INITIAL ACCU TNI RESULT WAS: 0.801NG/ML. THE REPEATED ACCU TNL RESULT WAS: 0.021NG/ML. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT THAT CAN BE ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR