COMBUR-9-TEST
Received Dec 13, 2019 · Event occurred Nov 19, 2019
Report 1823260-2019-04406 · MDR key 9465589
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04510046040
Lot number
39009003
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
THIS EVENT OCCURRED IN (B)(6). THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION. THE TEST STRIPS WERE RETURNED. THE TEST STRIPS SHOWED DISCOLORATIONS OF MULTIPLE PARAMETERS INCLUDING NITRITES. THE RETENTION MATERIAL SHOWED NO ABNORMALITIES. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF FALSE POSITIVE NITRITE RESULTS FOR MULTIPLE PATIENTS TESTED WITH COMBUR 9 URINE TEST STRIPS. THE TEST STRIPS ALWAYS SHOW A POSITIVE RESULT FOR NITRITES WHEN THE COMPARISON METHOD SHOWS A NEGATIVE RESULT. THE SPECIFIC COMPARISON METHOD WAS NOT PROVIDED. NO PATIENTS WERE TREATED BASED ON THE POSITIVE RESULTS.