BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIO ECG UTILIZATION SERVICE

    MDR report key: 4232648 · Received September 12, 2014

    Report

    Report Number
    3007208829-2014-00003
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 13, 2014
    Report Date
    September 12, 2014
    Manufacturer
    IRHYTHM TECHNOLOGIES INC.
    Product Code
    DQK
    PMA / PMN Number
    K091075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CLINIC'S PATIENT-DEVICE REGISTRATION PROCESS IS NOT ALWAYS COMPLETED BY THE SAME CLINICIAN AT THE TIME THE DEVICE IS APPLIED TO THE PATIENT. REGISTRATION RESPONSIBILITY IS SHARED BETWEEN CLINICAL STAFF MEMBERS. THIS PROCESS HAS INHERENT DELAYS AND POTENTIAL FOR INCORRECT PATIENT REGISTRATION TO THE DEVICE. THE CLINIC'S PATIENT REGISTRATION PROCESS IS NOT CONSIDERED BEST PRACTICES BY THE MANUFACTURER. THE CLINIC HAS IMPLEMENTED CORRECTIVE ACTIONS TO MITIGATE THE RISK OF REOCCURRENCE.

    Description of Event or Problem · 1

    THE CLINIC REGISTERED AND VERIFIED INCORRECT PATIENT DEMOGRAPHICS TO THE DEVICE CAUSING A MIX-UP OF ECG MONITORING RESULTS OF TWO PATIENTS. THE INCORRECT ECG REPORT WAS DELIVERED TO THE PHYSICIAN FOR INTERPRETATION; HOWEVER THE PATIENT DID NOT RECEIVE THERAPY FROM THE INCORRECT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564576 ZIO ECG UTILIZATION SERVICE ZEUS SYSTEM DQK IRHYTHM TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR