BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2230322 · Received September 1, 2011

    Report

    Report Number
    2122870-2011-03370
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT.SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CALIBRATION FAILURES WERE RESOLVED VIA BECKMAN COULTER INC. GUIDED TROUBLESHOOTING. NO ROOT CAUSE WAS DETERMINED FOR THE ELEVATED S0 RLUS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 THEY EXPERIENCED THREE CREATINE KINASE-MB ISOENZYME (CK-MB) CALIBRATION FAILURES ON THEIR ACCESS 2 IMMUNOASSAY SYSTEM. THROUGH TROUBLESHOOTING WITH BECKMAN COULTER INC. (BCI) CUSTOMER TECHNICAL SERVICES (CTS), THE CUSTOMER WAS ABLE TO GET A PASSING CK-MB CALIBRATION. THE PASSING CK-MB CALIBRATION HAD ELEVATED S0 CALIBRATOR RELATIVE LIGHT UNITS (RLUS) AS COMPARED TO IN-HOUSE QC RELEASE DATA. THE CUSTOMER WAS ADVISED BY BCI CTS TO CONTACT BCI IF THEY ARE SAW ISSUES WITH INSTRUMENT ASSAY LOW LEVEL QUALITY CONTROL RECOVERIES OR IND FLAGS FOR LOW LEVEL PATIENTS. NO FURTHER CONTACT HAS BEEN MADE BY THE CUSTOMER. NO PATIENT RESULTS WERE ASSOCIATED WITH THIS EVENT. HENCE, THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. SPECIFIC PATIENT INFORMATION, SAMPLE HANDLING/COLLECTION AND SYSTEM INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS CK-MB REAGENT