OtherJWM
ICON P/G3
Received Mar 10, 2000 · Event occurred Feb 11, 2000
Report 1423253-2000-00008 · MDR key 268404
Device
Generic name
Nuclear Medicine Computer
Manufacturer
Siemens Medical SystemsModel number
5249177Catalog number
*
Lot number
*
Product problems
- Mislabeled
Patient
UNKNOWN
- Misdiagnosis
Narrative
Description of Event or Problem
WHEN CREATING COMPOSITE FILE TO USE FOR THE CARDIAC REVIEW PROGRAM WITH A SELECTION OF REST/STRESS, THE DATASETS ARE MISLABELED ON THE COMPOSITE PAGE OF THE CARDIAC REVIEW PROGRAM. PT WAS MISDIAGNOSED DUE TO THIS OCCURRENCE.
Remedial action
- Other