COMBUR-10-TEST 100 STR.
Received Nov 19, 2018 · Event occurred Oct 31, 2018
Report 1823260-2018-04362 · MDR key 8085293
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04510062171
Lot number
32222102
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE RETENTION MATERIAL OF LOT 32222100 WAS VISUALLY CHECKED WITH NATIVE URINE, A NITRITE DILUTION SERIES AND A LEUCOCYTES DILUTION SERIES. THE RESULTS OF THE MEASUREMENTS FULFILL OUR REQUIREMENTS. NO FALSE POSTIVE RESULTS WERE OBSERVED.
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE CORRECT LENGTH OF TIME THE BOTTLE STRIPS WAS OPENED WAS PROVIDED AS 10 MONTHS.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE CUSTOMER STATED THAT THEY RECEIVED QUESTIONABLE FALSE POSITIVE NITRITE RESULTS FOR 3 TO 4 CHILDREN PATIENT URINE SAMPLES WHEN TESTING WITH COMBUR-10-TEST STRIPS. THE SPECIFIC NUMBER OF PATIENTS WAS NOT PROVIDED. THE CUSTOMER STATED THE BOTTLE WAS "OPENED 10 YEARS AGO". VERIFICATION ON HOW LONG THE BOTTLE OF TEST STRIPS HAS BEEN OPEN WAS REQUESTED BUT HAS NOT BEEN PROVIDED. IF THE LOT NUMBER PROVIDED BY THE CUSTOMER IS CORRECT THE TEST STRIPS WERE MANUFACTURED IN JANUARY 2018. THE NITRITE RESULTS WERE POSITIVE. THE EXPECTED RESULTS AND THE RESULTS WITH A DIFFERENT STRIP LOT WERE NEGATIVE. THE DIFFERENT STRIP LOT WAS NOT PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SUSPECT DEVICE WAS REQUESTED TO BE RETURNED FOR INVESTIGATION.