COMBUR-5-TEST 100 STR
Received Oct 8, 2019 · Event occurred Sep 18, 2019
Report 1823260-2019-03613 · MDR key 9165897
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11893467255
Lot number
39664402
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
UPON INSPECTION OF PHOTOGRAPHS OF THE AFFECTED VIALS AND TEST STRIPS, A PINK LIQUID WAS OBSERVED ON THE OUTSIDE OF ONE OF THE TEST STRIP VIALS AND ON ONE OF THE TEST STRIPS. THE NITRITE TEST PADS OF THE STRIPS APPEARED SLIGHTLY PINK. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH COMBUR 5 TEST STRIPS. THE ISSUE ONLY STARTED HAPPENING RECENTLY. THE AFFECTED PATIENT SAMPLES HAVE FALSE POSITIVE NITRITE RESULTS WHEN TESTED USING THE TEST STRIPS AND VISUALLY READING THE RESULTS FROM THE STRIP. NO SPECIFIC EXAMPLES OF AFFECTED PATIENT SAMPLES WERE PROVIDED. THE REPORTER STATES THE ISSUE OCCURRED WHEN USING TWO DIFFERENT VIALS OF TEST STRIPS. THE REPORTER STATED THERE WERE NO CRACKS IN THE TEST STRIP CONTAINERS/VIALS. THE NITRITE BLOCK ON THE TEST STRIP WAS SLIGHTLY PINK BEFORE TESTING.
Additional Manufacturer Narrative
RETENTION MATERIAL WAS CHECKED AND SHOWED NO ABNORMALITIES AND NO SIGNS OF DISCOLORATION. THE CUSTOMER DID NOT RETURN MATERIAL FOR INVESTIGATION, NO FURTHER INVESTIGATION IS POSSIBLE. PHOTOGRAPHS OF THE CUSTOMER'S TEST STRIPS SHOWED THE TEST STRIP WAS DISCOLORED BEFORE USE. THIS CAN CAUSE THE FALSE POSITIVE NIT RESULTS. IT IS CONSISTENT WITH THE STRIP VIAL NOT BEING CLOSED CORRECTLY OR OPENED FOR TOO LONG.