inforMED
OtherLMD

LEONARDO

Received Feb 24, 2004 · Event occurred Dec 1, 2003

Report 512499 · MDR key 512499

Device

Generic name

Radiology Imaging Workstation

Model number

LEONARDO

Catalog number

*

Lot number

*

Product problems

  • Mislabeled

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

A PHYSICIAN WAS REVEIWING CASES ON THE LEONARDO CT [COMPUTERIZED TOMOGRAPHY] WORKSTATION, REVIEWING IMAGES OF "PATEINT" AND NOTICED THAT APPARENTLY "PATIEN" B" 'S CT IMAGES HAD BEEN DOWNLOADED TO PATIENT A'S FOLDER AND THOSE IMAGES WERE INCORRECTLY LABELED WITH PATIENT A'S NAME AND ID NUMBER. PATIENT A AND PATIENT B IDENTIFIERS USED FOR CLARITY IN EXPLAINING THE SITUATION. THERE WERE MULTIPLE IMAGES DOWNLOADED TO THE WRONG FOLDER AND INCORRECTLY LABELED. ONLY THE FACT THAT THE TWO PATIENTS WERE QUITE DIFFERENT IN SIZE MADE THE SITUATION IMMEDIATELY OBVIOUS TO THE RADIOLOGIST. THIS OCCURRENCE HAS BEEN REPORTED TO THE MFR, WHO IS IN THE PROCESS OF INVESTIGATING THE CAUSE. CO DOES NOT BELIEVE ANY STUDIES PRIOR TO THIS ONE HAVE BEEN MIS-LABELED.