MalfunctionKGI

HOLOGIC QDR

Received Jan 18, 2011 · Event occurred Dec 22, 2010

Report 1971896 · MDR key 1971896

Device

Generic name

Bone Densitometer

Manufacturer

Hologic, Inc.

Model number

Catalog number

Lot number

Product problems

Display or Visual Feedback Problem

Patient

65 YR

No Information

Narrative

Description of Event or Problem

PATIENT UNDERGOING HER FIRST BONE DENSITOMETRY. WHEN THE STUDY WAS READ AND INTERPRETED, THE SOFTWARE ALLOWED A COMPARISON TO ANOTHER PATIENT'S STUDY. THIS WAS DISCOVERED WHEN THE PATIENT CALLED TO REPORT THAT SHE HAD NOT HAD A PREVIOUS STUDY TO COMPARE WITH. THE STUDY WAS RE-ANALYZED AND THE ERROR FOUND. DEPT IS CURRENTLY IN THE PROCESS OF RE-ANALYZING ALL STUDIES PERFORMED ON THIS EQUIPMENT TO BE SURE SAME OR SIMILAR ERROR DID NOT OCCUR.