URISYS 1100
Received Jun 6, 2014 · Event occurred May 7, 2014
Report 1823260-2014-04136 · MDR key 3854121
Device
Generic name
Automated Urine Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
03617548001
Lot number
NA
Product problems
- False Negative Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
CORRECTED INFORMATION: THE RESULT OF +2 FOR ERYTHROCYTES WAS OBTAINED ON THE URISYS 1100, WHILE A LABORATORY TEST REPORTED A VALUE OF NEGATIVE. THE SUSPECT PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.
Description of Event or Problem
REPORTER STATED THAT A NEGATIVE RESULT FOR ERYTHROCYTES WAS OBTAINED ON THE URISYS 1100 WHILE A LABORATORY TEST REPORTED THE RESULT AS +2. NO ADVERSE EVENT WAS REPORTED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.
Additional Manufacturer Narrative
THE EVENT OCCURRED IN (B)(6).