MalfunctionGMD
CRAG LFA
Received Apr 24, 2017 · Event occurred Nov 17, 2016
Report MW5069311 · MDR key 6521790
Device
Generic name
Crag Lfa
Manufacturer
ImmyProduct problems
- False Positive Result
- Device Operates Differently Than Expected
Patient
64 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PATIENT HAD BLOOD TEST FOR CRYPTOCOCCOSIS WITH FALSE POSITIVE RESULTS DUE TO ASSAY MALFUNCTION. THERAPY START DATE: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: CRYPTOCOCCOSIS.