BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1832597 · Received September 13, 2010

    Report

    Report Number
    2122870-2010-00521
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 13, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN THE ESTABLISHED RANGES. WHILE TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS FOUND THAT THE REAGENT PACK FOR DIFFERENT ASSAY WAS MISLOADED IN THE SLOT ASSIGNED FOR CKMB REAGENT IN THE REAGENT CAROUSEL. THE CUSTOMER STATED THEY HAD REPEATED ALL CKMB TESTING FOR PATIENT SAMPLES RUN ON THE MORNING OF THE EVENT. SERVICE WAS NOT DISPATCHED AS THE ISSUE WAS RESOLVED BY TROUBLESHOOTING WITH THE CTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED CKMB RESULTS ABOVE THE NORMAL REFERENCE RANGE GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER FOR THREE PATIENTS. ONE OF THE SAMPLES WAS TESTED AGAIN ON THE SAME AND A DIFFERENT INSTRUMENT. THE RESULT FROM DIFFERENT INSTRUMENT WAS DISCREPANT. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF DEATH, 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 SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1