COMBUR-7-TEST 100 STR.
Received Oct 22, 2019 · Event occurred Sep 25, 2019
Report 1823260-2019-03813 · MDR key 9218270
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11008552191
Lot number
38055002
Product problems
- False Negative Result
- False Negative Result
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER RETURNED ONE VIAL OF COMBUR-7-TEST 100 STR OF THE AFFECTED LOT FOR INVESTIGATION. THE TEST STRIPS SHOWED NO ABNORMALITIES. THE CUSTOMER MATERIAL AND RETENTION MATERIAL WERE VISUALLY CHECKED AND CHECKED WITH NEGATIVE URINE AND WITH AN ERYTHROCYTE DILUTION SERIES AND A NITRITE DILUTION SERIES. NEITHER MATERIALS SHOWED ABNORMALITIES, AND BOTH FULFILL REQUIREMENTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF FALSE NEGATIVE NITRITE RESULTS FOR 1 PATIENT URINE SAMPLE TESTED WITH COMBUR-7 URINE TEST STRIPS. THE NITRITE RESULT WAS NEGATIVE. THE PHYSICIAN'S RESULT WITH URISYS 1100 WAS POSITIVE. THE SOFTWARE VERSION WAS 5.71. THE CUSTOMER USED A DIFFERENT VIAL OF TEST STRIPS AND THE RESULTS MATCHED THE PHYSICIAN'S RESULTS. THE CUSTOMER DID NOT PERFORM QC.