BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® ACCUTNI¿

    MDR report key: 3112815 · Received May 14, 2013

    Report

    Report Number
    2122870-2013-00461
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THE DEVICE WAS RETURNED FOR EVALUATION. THE FIELD SERVICE ENGINEER (FSE) PERFORMED A SCHEDULED PREVENTATIVE MAINTENANCE (PM) ON THE INSTRUMENT AND COMPLETED HIGH SENSITIVITY SYSTEM CHECK AND SYSTEM CHECK SUCCESSFULLY. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED FALSE POSITIVE TROPONIN I (ACCESS ACCUTNI) RESULT, WITHIN THE RISK STRATIFICATION, FOR ONE PATIENT, INVOLVING THE ACCESS ACCUTNI ASSAY USED IN CONJUNCTION WITH THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM AND CALIBRATOR. SUBSEQUENT ANALYSIS OF THE PATIENT SAMPLE, ON AN ALTERNATE UNICEL DXI 800 INSTRUMENT, RECOVERED A LOWER RESULT, WITHIN THE NORMAL REFERENCE RANGE. REPEAT ANALYSIS OF THE SAME SAMPLE, ON THE ORIGINAL ANALYZER, RECOVERED HIGHER RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT. THE ERRONEOUS RESULT WAS RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. ON (B)(6) 2013, ASSAY CALIBRATION PASSED WITHIN SPECIFICATION. QUALITY CONTROL (QC) INFORMATION WAS NOT SUPPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212974 ACCESS® ACCUTNI¿ IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 227992

    Patients

    Seq Age Sex Outcome Treatment
    1