BEUDAMED
    FDA Adverse Event Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1903942 · Received November 20, 2010

    Report

    Report Number
    2122870-2010-00773
    Date Received
    November 20, 2010
    Date of Event
    October 23, 2010
    Report Date
    October 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE IN LIHEPARIN PLASMA TUBES AND CENTRIFUGED FOR 7 MINUTES AT 3500 RPM. SAMPLES ARE ASPIRATED FROM THE PRIMARY COLLECTION TUBE FOR ANALYSIS. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRE AND POST THE EVENT. ON (B)(6) 2010 SYSTEM CHECK WAS PERFORMED BY THE CUSTOMER AND IT MET SPECIFICATIONS. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK AND BOTH MET SPECIFICATIONS. NO HARDWARE ISSUES WERE NOTED BY THE FSE. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT. CHANGED FROM THE SAMPLES WERE IN LIHEPARIN PLASMA TUBES AND CENTRIFUGED FRO 7 MINUTES AT 3500 RPM. SAMPLES ARE ASPIRATED FROM THE PRIMARY COLLECTION TUBE FOR ANALYSIS. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR THE EVENT AND OUT OF RANGE AFTER THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK AND BOTH MET SPECIFICATIONS. NO HARDWARE ISSUES WERE NOTED BY FSE. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT. TO THE SAMPLES WERE IN LIHEPARIN PLASMA TUBES AND CENTRIFUGED FOR 7 MINUTES AT 3500 RPM. SAMPLES ARE ASPIRATED FROM THE PRIMARY COLLECTION TUBE FOR ANALYSIS. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRE AND POST THE EVENT. ON (B)(6) 2010 SYSTEM CHECK WAS PERFORMED BY THE CUSTOMER AND IT MET SPECIFICATIONS. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK AND BOTH MET SPECIFICATIONS. NO HARDWARE ISSUES WERE NOTED BY THE FSE. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE IN LIHEPARIN PLASMA TUBES AND CENTRIFUGED FRO 7 MINUTES AT 3500 RPM. SAMPLES ARE ASPIRATED FROM THE PRIMARY COLLECTION TUBE FOR ANALYSIS. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR THE EVENT AND OUT OF RANGE AFTER THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK AND BOTH MET SPECIFICATIONS. NO HARDWARE ISSUES WERE NOTED BY FSE. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO TWO (2) ERRONEOUS ELEVATED ACCUTNL RESULTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE SAMPLES WERE REPEATED ON THE SAME UNIT AND TESTING RESULTS IN THE RISK STRATIFICATION RANGE AND SUBSEQUENT SAMPLE RESULTED IN THE NORMAL REFERENCE RANGE. THE ELEVATED RESULTS WERE REPORTED OUT OF THE LABORATORY. UNKNOWN IF PATIENT TREATMENT WAS ADMINISTERED OR WITHHELD.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO TWO (2) ERRONEOUS ELEVATED ACCUTNL RESULTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE SAMPLES WERE REPEATED ON THE SAME UNIT AND TESTING RESULTS IN THE RISK STRATIFICATION RANGE AND SUBSEQUENT SAMPLE RESULTED IN THE NORMAL REFERENCE RANGE. THE ELEVATED RESULTS WERE REPORTED OUT OF THE LABORATORY. UNKNOWN IF PATIENT TREATMENT WAS ADMINISTERED OR WITHHELD.

    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 68 YR