MalfunctionKGI
SAHARA BONE DENSITOMETER
Received May 29, 2002 · Event occurred May 7, 2002
Report MW1025195 · MDR key 397421
Device
Generic name
Ultrasound Bone Densitometer
Manufacturer
Hologic IncModel number
*Catalog number
*
Lot number
*
Product problems
- False Reading From Device Non-Compliance
Patient
40 YR
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
PT HAD A SAHARA BONE DENSITY SCREENING OF LEFT HEEL THAT REPORTED SCORE OF -1.8 INDICATING HIGH RISK OF DEVELOPING OSTEOPOROSIS. A SECOND SCAN OF RIGHT HEEL GAVE A SCORE OF -1.7. FOLLOWUP DEXA SCAN INDICATED T SCORE OF +.90 FOR LUMBAR SPINE AND -.1 FOR LEFT HIP. NO ONE HAS BEEN ABLE TO EXPLAIN WHY THEY GOT SUCH MISLEADING RESULTS FROM THE SAHARA SCAN. PT IS OUT OF POCKET OVER $400 FOR THE DEXA SCAN SINCE INSURANCE WON'T COVER IT BECAUSE IT WAS NECESSARY AT PT'S AGE.