COBAS U 601 URINE ANALYZER
Received Jul 9, 2020 · Event occurred Jun 14, 2020
Report 1823260-2020-01649 · MDR key 10252001
Device
Generic name
Automated Urine Analyzer
Manufacturer
Roche DiagnosticsModel number
U 601Catalog number
06390498001
Lot number
NA
Product problems
- False Positive Result
- False Positive Result
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE MICROSCOPIC BACTERIAL DETERMINATION WAS PERFORMED ON A COBAS U 701 SYSTEM AND THE INVESTIGATION DETERMINED THE VALUE TO BE NEGATIVE. THE COBAS U 701 SYSTEM IS NOT RELEASED FOR DISTRIBUTION IN THE UNITED STATES. 100 % CORRELATION IS NOT POSSIBLE WHEN COMPARING THE COBAS U 601 NITRITE MEASUREMENT TO THE MICROSCOPIC BACTERIAL DETERMINATION ON THE U 701 AS BOTH SYSTEMS USE DIFFERENT TECHNOLOGY. THE AMOUNT OF BACTERIA WAS BORDERLINE, CAUSING THE U 601 TO DISPLAYING A POSITIVE NITRITE VALUE COMPARED TO THE NEGATIVE MICROSCOPIC BACTERIAL DETERMINATION ON THE U 701. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED FALSE POSITIVE NITRITE RESULTS FOR THREE PATIENT SAMPLES TESTED ON A COBAS U 601 ANALYZER. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. FOR ALL THREE SAMPLES, THE NITRITE RESULTS WERE POSITIVE. THE POSITIVE VALUES DID NOT AGREE WITH THE MICROSCOPIC BACTERIAL RESULTS AND MANUAL TESTING OF TEST STRIPS. SAMPLES 1 AND 2 WERE TESTED ON (B)(6) 2020 AND THE THIRD SAMPLE WAS TESTED ON (B)(6) 2020. THE TEST STRIP LOT NUMBER WAS 43071100, WITH AN EXPIRATION DATE OF 30-SEP-2020.