BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2080837 · Received May 6, 2011

    Report

    Report Number
    2122870-2011-01262
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    February 1, 2011
    Report Date
    April 7, 2011
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WERE NOT SUPPLIED. LAB HAS IMPLEMENTED A REPEAT PROTOCOL ON ALL TROPONIN I RESULTS THAT RECOVER GREATER THAN 0.2 NG/ML. SYSTEM CHECK DATA WAS NOT SUPPLIED. CUSTOMER DID NOT PROVIDE ANY INFORMATION INDICATING INSTRUMENT MALFUNCTION. SERVICE WAS NOT DISPATCHED, AS CUSTOMER WAS NOT QUESTIONING INSTRUMENT PERFORMANCE. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    WHEN CONTACTED BY BECKMAN COULTER INC. (BCI) REGARDING ACCUTNI ASSAY PERFORMANCE, THE CUSTOMER STATED THAT THEIR LABORATORY HAD OBTAINED A FALSE POSITIVE TROOPONIN (ACCUTNI) RESULT ABOVE THE AMI CUTOFF FOR ONE (1) PATIENT, GENERATED BY THE ACCESS 2 INSTRUMENT. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LAB. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1