COMBUR 6-TEST 50 STR.
Received Mar 9, 2020 · Event occurred Feb 19, 2020
Report 1823260-2020-00678 · MDR key 9806639
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11896962257
Lot number
39008702
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 INVESTIGATION IS ONGOING. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE FALSE POSITIVE URINE NITRITE RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES. THE CUSTOMER STATED THE TEST PADS WERE DISCOLORED AND THE PAD LOOKED PINK BEFORE TESTING. IT WAS UNKNOWN IF ANY QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE CUSTOMER¿S PRODUCTS HAVE BEEN REQUESTED FOR RETURN. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW UP REPORT WILL BE SUBMITTED. THE RETENTION MATERIAL OF LOT 39008700 WAS MEASURED BY VISUAL READING WITH A NITRITE DILUTION SERIES AND NATIVE URINE. THE RETENTION MATERIAL FULFILLED THE REQUIREMENTS AND NO FALSE POSITIVE RESULTS OBSERVED.