BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNCHECK - DOSECHECK MODULE

    MDR report key: 8884913 · Received August 12, 2019

    Report

    Report Number
    1038814-2019-00001
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 11, 2019
    Report Date
    August 9, 2019
    Manufacturer
    SUN NUCLEAR CORPORATION
    Product Code
    IYE
    PMA / PMN Number
    K170307
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SOFTWARE WAS EVALUATED BY THE MANUFACTURER AND IT WAS DETERMINED THAT SOME OF THE PRECONFIGURED DOSIMETRIC TEMPLATES CURRENTLY AVAILABLE IN THE SOFTWARE (FOR EXAMPLE, TG-101) MAY NOT CONTAIN ALL METRICS IN THE PUBLISHED PROTOCOLS. FURTHERMORE, THE METRICS USED MAY NOT REFLECT THE INTENT OF THE PROTOCOL. THIS MAY RESULT IN A TREATMENT PLAN HAVING PASSING RESULTS IN THE DOSECHECK MODULE OF SUNCHECK PATIENT WITHOUT MEETING ALL OF THE RECOMMENDED CRITERIA OUTLINED WITHIN THE PROTOCOL.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Description of Event or Problem · 1

    INITIAL CUSTOMER INQUIRY STATED: "CUSTOMER CALLED DUE TO ATTEMPTING TO SETUP METRICS WITH TG101 PROTOCOL SHE CAME TO THE PARALLEL TISSUE(S) LUNG, LIVER AND RENAL CORTEX AND IT REQUIRES A MINIMUM CRITICAL VOLUME AND UNFORTUNATELY WE ONLY ALLOW TO SET FOR MAXIMUM. THEREFORE IT WILL NOT REALLY REFLECT CORRECTLY AS FAR AS PASSING RESULTS." NOTE: NO REPORTED PATIENT INJURY OR DEATH OCCURRED. REF FDA MEDWATCH REPORT: MW5088230. ON AUGUST 1, 2019 SUN NUCLEAR RECEIVED A LETTER FROM THE FDA STATING THAT GRAND STRAND MEDICAL CENTER FILED AN MDR REPORT FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677985 SUNCHECK - DOSECHECK MODULE RADIOLOGIC QUALITY ASSURANCE INSTRUMENT IYE SUN NUCLEAR CORPORATION V1.3.2

    Patients

    Seq Age Sex Outcome Treatment
    1