BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2190008 · Received August 3, 2011

    Report

    Report Number
    2122870-2011-02639
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONFIRMATORY SAMPLE TESTING DID NOT INDICATE THAT AN INSTRUMENT MALFUNCTION HAD OCCURRED OR ERRONEOUS RESULTS HAD BEEN GENERATED. NOR DID IT CONFIRM THAT AN INTERFERENT WAS PRESENT IN THE PATIENT SAMPLES. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ELEVATED CARDIAC TROPONIN (ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION RANGE, WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT OVER TWO DAYS. THE PATIENT'S CREATINE KINASE (CK) TEST RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE DURING THE TIMEFRAME OF THIS EVENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL BASED UPON THE ELEVATED ACCUTNI RESULTS. A PHYSICIAN LATER QUESTIONED THE RESULTS AND INQUIRED AS TO WHETHER HETEROPHILE INTERFERENCE MIGHT BE A CAUSAL AGENT TO THE ELEVATED ACCUTNI RESULTS. SUBSEQUENT CUSTOMER TESTING OF TWO ADDITIONAL SAME-PATIENT SAMPLES CONFIRMED INITIAL RESULTS; HENCE THERE IS NO EVIDENCE THAT ERRONEOUS RESULTS WERE GENERATED. BECKMAN COULTER INC. CUSTOMER PRODUCT LINE SUPPORT (CPLS) TESTING WAS PERFORMED ON A CUSTOMER RETURNED SAMPLE. CPLS RESULTS CONFIRMED THE PREVIOUSLY ELEVATED ACCUTNI GENERATED RESULTS. PATIENT SAMPLE SOURCED INTERFERENCE COULD NOT BE CONFIRMED WITH THE PATIENT SAMPLES THAT WERE PROVIDED. INSTRUMENT ACCUTNI QUALITY CONTROL RESULTS WERE PERFORMING WITHIN CUSTOMER ESTABLISHED RANGES DURING THE TIMEFRAME OF THE EVENT. AN INSTRUMENT SYSTEM CHECK PERFORMED PRIOR TO THE EVENT PASSED INSTRUMENT ESTABLISHED SPECIFICATIONS. THE SAMPLES WERE PLASMA SAMPLES COLLECTED IN LITHIUM HEPARIN TUBES AND CENTRIFUGED PRIOR TO TESTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R ACCESS ACCUTNI - REAGENT