COMBUR-10-TEST 100 STR.

Additional Manufacturer Narrative

THE REPORTER'S REMAINING TEST STRIPS WERE PROVIDED FOR INVESTIGATION WHERE BOTH THESE STRIPS AND RETENTION TEST STRIPS WERE TESTED USING NATIVE URINE SPIKED WITH AN ERYTHROCYTE DILUTION SERIES. THE TEST STRIP VIAL RETURNED FROM THE CUSTOMER WAS NOT CLOSED PROPERLY. ALL TEST STRIPS IN THE VIAL SHOWED NO ABNORMALITIES OR SIGNS OF DISCOLORATION. 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.