MAUDE Adverse Event Report: SUN NUCLEAR CORPORATION SUNCHECK - DOSECHECK MODULE; RADIOLOGIC QUALITY ASSURANCE INSTRUMENT

Model Number V1.3.2

Device Problem Application Program Problem (2880)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: SUNCHECK - DOSECHECK MODULE
• Type of Device: RADIOLOGIC QUALITY ASSURANCE INSTRUMENT
• Manufacturer (Section D): SUN NUCLEAR CORPORATION; 3275 suntree blvd; melbourne FL 32940
• MDR Report Key: 8884913
• MDR Text Key: 216414709
• Report Number: 1038814-2019-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K170307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V1.3.2
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 07/11/2019
• Supplement Dates FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1