Issues noticed with Pinnacle 21 Community Version 2.2 related to DU (Device in Use) Domain

Hi Team,

I have encountered couple of issues when I ran Pinnacle 21 Community V2.2 on DU domain.

• In DU domain there is only one record per USUBJID and DUSEQ =1 for all the subjects. When I ran Pinnacle 21 Community V2.2 it is throwing an "ERROR" SD1236- "Duplicate value for DUSEQ variable" for 99 records out of 100 records. I am not sure what Pinnacle 21 is looking for even though the records are unique. Let me know if I am missing anything here.
• We have used following variable labels for DUTESTCD and DUTEST as per SDTMIG Medical Device V1.0

- DUTESTCD = “Device In-Use Test Short Name”

- DUTEST= “Device In-Use Test Name” 

• However we got a warning SD0063-"SDTM/dataset variable label mismatch". When I checked SDTM MD in configuration file the label is different. If I use this label I know the warning will be suppressed, but as per the rule - SD0063 “Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted.”

- DUTESTCD = “Device In- Use Test Short Name”

- DUTEST= “Device In- Use Test Name” 

Looks like there is a space after the “-“ in the SDTM MD.xml file  labels it is really not clear for us which variable label do we need to use. Please let us know. I would really appreciate your response.

Thank you,

Sai Krishna.