BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS DIGOXIN REAGENT

    MDR report key: 6908255 · Received October 2, 2017

    Report

    Report Number
    2122870-2017-00050
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    September 8, 2017
    Report Date
    September 11, 2017
    Manufacturer
    BECKMAN COULTER
    Product Code
    KXT
    UDI-DI
    15099590225797
    PMA / PMN Number
    K925802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY, AND RACE. THE ACCESS DIGOXIN REAGENT WAS NOT RETURNED FOR EVALUATION. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LABORATORY TO EVALUATE THE PERFORMANCE OF THE INSTRUMENT. THE FSE PERFORMED PREVENTATIVE MAINTENANCE. THERE WAS NO REPORT OF A SYSTEM PERFORMANCE ISSUE THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. IN CONCLUSION. AN ASSIGNABLE CAUSE FOR THIS EVENT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THERE IS NO EVIDENCE TO REASONABLY SUGGEST A SYSTEM MALFUNCTION; SYSTEM PARAMETERS (SYSTEM CHECKS, LEVEL SENSE DIAGNOSTIC TESTING, QC) MET ASSAY AND INSTRUMENT SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE DIGOXIN (ACCESS DIGOXIN) RESULTS ON THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE PATIENT'S SAMPLE WAS ANALYZED IN TRIPLICATE AND RECOVERED WITH IMPRECISE ACCESS DIGOXIN RESULTS. THESE RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE WAS NO IMPACT OR CHANGE TO PATIENT CARE OR TREATMENT IN ASSOCIATION WITH THE NON-REPRODUCIBLE ACCESS DIGOXIN RESULTS. QUALITY CONTROL (QC) WAS RECOVERING WITHIN SPECIFICATIONS PRIOR TO THE EVENT. THE CUSTOMER REPORTED THAT QC WAS OUT OF SPECIFICATIONS THE DAY FOLLOWING THIS EVENT. THE PATIENT'S SAMPLE WAS COLLECTED IN A PLASMA SEPARATION TUBE. THE CUSTOMER WAS NOT ABLE TO PROVIDE CENTRIFUGE INFORMATION SUCH AS SPEED, TIME OR TEMPERATURE. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686499 ACCESS DIGOXIN REAGENT ENZYME IMMUNOASSAY, DIGOXIN KXT BECKMAN COULTER 33710 633010 15099590225797

    Patients

    Seq Age Sex Outcome Treatment
    1