BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® ACCUTNI?

    MDR report key: 3232429 · Received July 18, 2013

    Report

    Report Number
    2122870-2013-00624
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THE ACCESS ACCUTNI DEVICE WAS RETURNED FOR EVALUATION. ALL SYSTEM PARAMETERS INCLUDING QUALITY CONTROL (QC), CALIBRATIONS AND SYSTEM CHECKS WERE PERFORMING WITHIN THE ASSAY AND INSTRUMENT SPECIFICATIONS. ADDITIONALLY, ASSAY QC WAS PERFORMING WITHIN THE LABORATORY'S ESTABLISHED RANGES ON THE DAY OF THE EVENT. NO ISSUES WERE NOTED WITH SAMPLE COLLECTION, SAMPLE PROCESSING, OR SAMPLE HANDLING. THE FSE FOUND ONE OF THE PERI-PUMP TUBING LOOSE FROM THE LIQUID WASTE SIDE OF THE PERI-PUMP. THE TUBING IS USED TO EVACUATE THE VACUUM JAR. THE LOOSE TUBING IS NOT RELATED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING AN ERRONEOUSLY ELEVATED TROPONIN I (ACCUTNI) RESULT OF 1.25 NG/ML FOR ONE (B)(6) FEMALE PATIENT ON THE ACCESS 2 ANALYZER (SERIAL NUMBER (B)(4)). SUBSEQUENT TESTING OF THE PATIENT'S SAMPLE ON THE SAME ANALYZER AND ON AN ALTERNATE ACCESS 2 ANALYZER PRODUCED LOWER RESULTS, WITHIN THE ASSAY'S RISK STRATIFICATION RANGE OF 0.05 NG/ML. ALTHOUGH THE CLINICIAN QUESTIONED THE INITIAL ELEVATED RESULT, THE PATIENT WAS ADMITTED TO THE HOSPITAL. THERE IS NO INDICATION THAT FURTHER TREATMENT WAS PROVIDED TO THE PATIENT AFTER ADMITTANCE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO EVALUATE THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335707 ACCESS® ACCUTNI? IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 231302

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization