MalfunctionJIO

URISYS 1100

Received Feb 26, 2008 · Event occurred Jan 31, 2008

Report 1823260-2008-01842 · MDR key 1006898

Device

Generic name

Automated Urine Analyzer

Manufacturer

Roche Diagnostics

Model number

U1100

Catalog number

03617556690

Product problems

Low Test Results

Patient

UNK

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

Narrative

Description of Event or Problem

ONE PT URINE SAMPLE WITH DISCREPANT RESULTS FOR BLOOD, COMPARED TO REPEAT RESULTS FROM ANOTHER ANALYZER - SAME METHODOLOGY. INITIAL RESULT GAVE 50 UL; REPEAT RESULTED NEGATIVE. MICROSCOPIC EXAM OF SAME SAMPLE SHOWED NEGATIVE FOR BLOOD. NO ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THE RESULTS. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.