BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2163014 · Received July 15, 2011

    Report

    Report Number
    2122870-2011-02275
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 19, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) PERFORMED A ROUTINE SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK. BOTH GENERATED ACCEPTABLE RESULTS WITHIN ESTABLISHED SPECIFICATIONS. THE FSE VERIFIED ULTRASONIC PERFORMANCE WITH NO ISSUES NOTED. NO HARDWARE ISSUES WERE IDENTIFIED. THE INSTRUMENT PERFORMED ACCORDING TO SPECIFICATION. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. MDR ASSOCIATED WITH THIS EVENT: 2122870-2011-02276.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRATIC AND ERRONEOUS CARDIAC TROPONIN (ACCUTNI) RESULTS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PATIENT SAMPLES. THIS IS REPORT ONE OF TWO AND REPRESENTS ERRATIC CARDIAC TROPONIN (ACCUTNI) RESULTS, WITHIN THE NORMAL REFERENCE RANGE, WITHIN THE RISK STRATIFICATION RANGE AND ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) THRESHOLD RESPECTIVELY, GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT SAMPLE ON (B)(6) 2011. THESE ACCUTNI RESULTS WERE REPORTED OUT OF THE LABORATORY. THE PATIENT WAS TRANSFERRED TO A HEART HOSPITAL BASED UPON THE ERRATIC ACCUTNI RESULTS. IT IS UNKNOWN WHETHER THERE WAS MODIFICATION TO PATIENT TREATMENT POST HOSPITAL TRANSFER. INSTRUMENT ACCUTNI QUALITY CONTROL RESULTS WERE PERFORMING WITHIN CUSTOMER ESTABLISHED RANGES PRIOR TO, AND ON THE DAY OF THE EVENT. THE DAY AFTER THE EVENT, ACCUTNI QC RESULTS RECOVERED 2 STANDARD DEVIATIONS LOWER. PREVENTIVE MAINTENANCE PERFORMED PRIOR TO THE EVENT PASSED INSTRUMENT ESTABLISHED SPECIFICATIONS. AT THE TIME OF THE EVENT, THE CUSTOMER INDICATED THAT THEY REMOVED THE ACCUTNI REAGENT PACK AND IDENTIFIED "BUBBLES AT THE TOP", SO THE REAGENT PACK WAS REPLACED. THE INITIAL SAMPLE WAS COLLECTED IN A PLASTIC SAMPLE TUBE WITH A GEL SEPARATOR AND CENTRIFUGED PRIOR TO TESTING. IT WAS STORED AT ROOM TEMPERATURE. THE SAMPLE APPEARED "NORMAL" IN APPEARANCE WITHOUT ANY VISIBLE ABNORMALITIES.

    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 85 YR Hospitalization| R ACCESS ACCUTNI