MalfunctionJIO

URISYS 1100

Received Feb 25, 2008 · Event occurred Jan 30, 2008

Report 1823260-2008-01843 · MDR key 1006896

Device

Generic name

Automated Urine Analyzer

Manufacturer

Roche Diagnostics

Model number

U1100

Catalog number

03617556690

Product problems

Low Test Results

Patient

34 YR

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

Narrative

Description of Event or Problem

ONE PT URINE SAMPLE THAT RESULTED NEGATIVE FOR BLOOD. VISUAL DIPSTICK OF SAME SHOWED 2+ OR 3+ FOR BLOOD. URINE SAMPLE REPEATED AN ADD'L TIME GIVING THE SAME RESULTS. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.