BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® ACCUTNI?

    MDR report key: 3171378 · Received June 14, 2013

    Report

    Report Number
    2122870-2013-00546
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THE ACCESS ACCUTNI DEVICE WAS RETURNED FOR EVALUATION. THE FIELD SERVICE ENGINEER (FSE) VERIFIED ALIGNMENT, MIXER SPEED, TRANSDUCER VOLTAGE AND THE VACUUM SYSTEM, NO ISSUES WERE NOTED. THE FSE CHECKED FOR LEAKS IN THE PRECISION AND WASH PUMPS AND CLEANED THE VALVES. THE FSE PERFORMED A ROUTINE SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK, WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS AND NO SYSTEM HARDWARE ISSUES WERE NOTED. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ONE INITIALLY ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULT, WITHIN THE RISK STRATIFICATION, FOR ONE PATIENT, INVOLVING THE ACCESS ACCUTNI ASSAY UTILIZED IN CONJUNCTION WITH THE ACCESS 2 IMMUNOASSAY SYSTEM AND ACCESS ACCUTNI CALIBRATOR. THE ERRONEOUS RESULT WAS RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN AS IT DID NOT CORRELATE WITH THE PATIENT¿S CLINICAL CONDITION. THE PATIENT WAS ADMITTED TO THE HOSPITAL BASED ON THE ELEVATED RESULT. IT IS UNKNOWN IF ANY ADDITIONAL TREATMENT WAS GIVEN TO THE PATIENT. THERE HAS BEEN NO REPORT OF CURRENT OUTCOME. SUBSEQUENT TESTING OF THE PATIENT¿S SERIAL DRAWS, ON THE SAME INSTRUMENT, PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE PATIENT¿S SAMPLE WAS COLLECTED IN A 13X100 MM LITHIUM HEPARIN TUBE WITHOUT GEL AND CENTRIFUGED AT 3,500 RPM (ROTATIONS PER MINUTE) FOR TEN MINUTES, AT ROOM TEMPERATURE. THE CUSTOMER STATED QUALITY CONTROL (QC) IS PERFORMED ONCE DAILY AND HAD BEEN WITHIN SPECIFICATIONS WITH NO ISSUES. SYSTEM CHECK, PERFORMED ON (B)(6) 2013, WAS WITHIN SPECIFICATION FOR ALL PARAMETERS. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271971 ACCESS® ACCUTNI? IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization