COMBUR-10-TEST 100 STR.
Received Jun 18, 2019 · Event occurred Apr 2, 2019
Report 1823260-2019-02229 · MDR key 8707315
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04510062171
Lot number
30953102
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
RETENTION TEST STRIPS WERE TESTED USING NATIVE URINE SPIKED WITH AN ERYTHROCYTE DILUTION SERIES. THE RESULTS OF ALL TEST STRIP MEASUREMENTS FULFILLED REQUIREMENTS AND NO FALSE NEGATIVE RESULTS WERE OBSERVED. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER STATED THAT THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT URINE SAMPLE TESTED WITH COMBUR 10 TEST STRIPS. IT WAS ASKED, BUT IT IS NOT KNOWN IF AN INCORRECT RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SPECIFIC DATE OF THE EVENT IS NOT KNOWN. THE REPORTER INITIALLY REPORTED THE COMPLAINT TO THE (B)(6) REGULATORY AUTHORITIES ON (B)(6) 2019. UPON VISUALLY READING THE ERYTHROCYTE/HEMOGLOBIN TEST ON THE TEST STRIP, THE TEST DOES NOT INDICATE SIGNS OF HEMOGLOBIN OR MYOGLOBIN IN THE URINE. MICROSCOPIC EXAMINATION OF THE SAME SAMPLE INDICATES THE PRESENCE OF ERYTHROCYTES AT CONCENTRATIONS OF 50 ERYTHROCYTES/UL. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE REPORTER'S PRODUCT WAS REQUESTED FOR INVESTIGATION.