COMBUR 5-TEST HC 10 STR.
Received Jun 24, 2019 · Event occurred Jun 4, 2019
Report 1823260-2019-02293 · MDR key 8727878
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11896954176
Lot number
37377601
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION. THE RETENTION MATERIAL OF LOT 373776 WAS TESTED WITH A NITRITE-, A PROTEIN-, A GLUCOSE-, AN ERYTHROCYTES-, A LEUCOCYTES-DILUTION-SERIES AND 0-NATIVE-URINE. THE RETENTION MATERIAL SHOWED NO FALSE NEGATIVE RESULTS OR ABNORMALITIES. THE MATERIAL MEETS THE REQUIREMENTS.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF FALSE NEGATIVE RESULTS FOR 1 PATIENT TESTED WITH COMBUR 5 URINE TEST STRIPS. THE PATIENT WAS TESTED IN SURGERY BY AN UNKNOWN METHOD WITH POSITIVE RESULTS FOR NITRITE, LEUCOCYTES AND ERYTHROCYTES. THE PATIENT WAS TESTED IN THE PHARMACY WITH COMBUR 5 TEST STRIPS AND RECEIVED NEGATIVE RESULTS FOR NITRITE, LEUCOCYTES AND ERYTHROCYTES. NO OTHER SPECIFICS RELATED TO THE EVENT OR RESULTS COULD BE PROVIDED BY THE REPORTER. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE PATIENT IS FINE.
Additional Manufacturer Narrative
THE CUSTOMER RETURNED ONE VIAL CONTAINING 3 STRIPS WHICH SHOWED NO VISUAL ABNORMALITIES. THE CUSTOMER RETURNED MATERIAL WAS TESTED AN ERYTHROCYTES-DILUTION-SERIES, A LEUCOCYTES-DILUTION-SERIES AND 0-NATIVE-URINE. THE INVESTIGATION FOUND NO FALSE-NEGATIVE RESULTS, FULFILLING THE REQUIREMENTS. MEDWATCH SECTIONS CONCOMITANT MEDICAL PRODUCTS AND DEVICE EVALUATED BY MFR HAVE BEEN UPDATED.