CHEMSTRIP ® 10 MD
Received Nov 20, 2019 · Event occurred Oct 18, 2019
Report 1823260-2019-04138 · MDR key 9349376
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
03260763160
Lot number
34762802
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE RETENTION MATERIAL OF TEST STRIP LOT 347628 WAS MEASURED ON A RETENTION COBAS U411 / URISYS 1800 AND WAS CHECKED BY VISUAL READING WITH NATIVE URINE AND A ERYTHROCYTES DILUTION SERIES. THE RETENTION MATERIAL OF TEST STRIP LOTS LOT 362550 AND 380554 WERE MEASURED ON A RETENTION COBAS U411 / URISYS 1800 AND WERE CHECKED BY VISUAL READING WITH NATIVE URINE, A ERYTHROCYTES DILUTION SERIES AND A NITRITE DILUTION SERIES. THE RETENTION MATERIAL OF LOT 368970 WAS MEASURED ON A RETENTION COBAS U411 / URISYS 1800 AND WAS CHECKED BY VISUAL READING WITH NATIVE URINE AND A NITRITE DILUTION SERIES. THE RETENTION MATERIAL SHOWED NO FALSE POSITIVE OR NEGATIVE RESULTS AND FULFILLED REQUIREMENTS.
Additional Manufacturer Narrative
THE REPORTER'S PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION AND REPLACEMENT PRODUCT WAS SENT TO THE REPORTER.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY HAVE RECEIVED QUESTIONABLE TEST RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED USING MULTIPLE CHEMSTRIP 10 MD TEST STRIP LOT NUMBERS WITH MULTIPLE URISYS 1100 ANALYZERS. THE RESULTS MEASURED USING THE ANALYZERS DID NOT MATCH RESULTS OBTAINED WITH A VISUAL READING OF THE TEST STRIPS. THE ISSUES OCCURRED AFTER INSTALLING A NEW SOFTWARE VERSION ((B)(6)) ON EACH URISYS 1100 ANALYZER. THE REPORTER PROVIDED DATA FOR A TOTAL OF 60 PATIENT SAMPLES AND OF THESE, 9 HAD DISCREPANT TEST RESULTS WHEN TESTED WITH THE FOLLOWING DEVICES: URISYS 1100 ANALYZER SERIAL NUMBER (B)(4) USED WITH TEST STRIP LOT NUMBER 38055401 (EXPIRATION DATE = 30-APR-2020). URISYS 1100 ANALYZER SERIAL NUMBER (B)(4) USED WITH TEST STRIP LOT NUMBER 36255001 (EXPIRATION DATE = 31-JAN-2020). URISYS 1100 ANALYZER SERIAL NUMBER (B)(4) USED WITH TEST STRIP LOT NUMBER 36897002 (EXPIRATION DATE = 29-FEB-2020). URISYS 1100 ANALYZER SERIAL NUMBER (B)(4) USED WITH TEST STRIP LOT NUMBER 38055405 (EXPIRATION DATE = 30-APR-2020). URISYS 1100 ANALYZER SERIAL NUMBER (B)(4) USED WITH TEST STRIP LOT NUMBER 34762802 (EXPIRATION DATE = 30-NOV-2019). THE AFFECTED TESTS INCLUDE NITRITE AND ERYTHROCYTES.