COMBUR-9-TEST
Received Aug 5, 2019 · Event occurred Jun 11, 2019
Report 1823260-2019-02822 · MDR key 8859507
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04510046040
Lot number
37376503
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 7 VIALS. ALL THE BOXES WERE RECEIVED ORIGINALLY PACKED. ALL THE BOXES SHOWED NO SIGNS OF DAMAGE AND EACH BOX CONTAINED 100 OF 100 TEST STRIPS. ALL RECEIVED TEST STRIPS SHOW NO SIGNS OF DISCOLORATION. BOTH THE CUSTOMER TEST STRIPS AND RETENTION TEST STRIPS OF LOT 37376500 WITH TESTED WITH NATIVE URINE AND A NITRITE-DILUTION SERIES. THE CUSTOMER TEST STRIPS AND THE RETENTION TEST STRIPS SHOWED NO FALSE-NEGATIVE RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED THAT THE NITRITE RESULTS FROM THE COMBUR 9 TEST STRIPS ARE ALWAYS NEGATIVE. THE CUSTOMER MENTIONED THAT FOR 1 PATIENT'S URINE SAMPLE THE COMBUR 9 TEST STRIP NITRITE RESULT WAS NEGATIVE, BUT MICROSCOPIC ANALYSIS OF THE SAME PATIENT'S URINE SAMPLE WAS POSITIVE FOR BACTERIA AND LEUKOCYTES. IT WAS UNKNOWN IF THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.