COMBUR 5-TEST HC 10 STR.

Additional Manufacturer Narrative

THE CUSTOMER RETURNED ONE VIAL OF LOT 37377601 COMBUR 5-TEST HC 10 STR., CONTAINING 4 OF 10 TEST STRIPS FOR INVESTIGATION. THE CUSTOMER MATERIAL AND RETENTION MATERIAL SHOW NO ABNORMALITIES AND NO SIGNS OF DISCOLORATION. NO FALSE NEGATIVE RESULTS WERE OBSERVED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF FALSE NEGATIVE RESULTS FOR 1 PATIENT USING COMBUR 5 URINE TEST STRIPS. THE PATIENT FIRST NOTICED HEALTH PROBLEMS ON (B)(6) 2019 WHICH INCLUDED CRAMPS AND BURNING WHILE URINATING. AS A BLADDER INFECTION WAS SUSPECTED THE PATIENT TOOK AN UNKNOWN HERBAL MEDICINE. ON (B)(6) 2019 THE TEST STRIPS HAD A 1+ RESULT FOR AN UNKNOWN TEST PARAMETER. ON (B)(6) 2019 THE TEST STRIP MEASUREMENTS WERE NEGATIVE. ON (B)(6) 2019 THE PATIENT HAD NEGATIVE RESULTS FROM THE TEST STRIPS AND THE PATIENT WENT TO THE DOCTOR'S OFFICE AS THEIR HEALTH PROBLEMS WERE STILL NOT RESOLVED. AT THE DOCTOR'S OFFICE USING AN UNKNOWN MEASUREMENT METHOD, THE PATIENT HAD POSITIVE ERYTHROCYTES AND LEUCOCYTES RESULTS (3+). ON (B)(6) 2019 THE DOCTOR GAVE THE PATIENT AN UNSPECIFIED ANTIBIOTIC AS THE PATIENT WAS DIAGNOSED WITH CYSTITIS. THE PATIENT'S CURRENT CONDITION WAS PROVIDED AS "FEELS FINE." THERE WAS NO INFORMATION PROVIDED TO REASONABLY SUGGEST THAT THE PATIENT WAS ADVERSELY AFFECTED. THE AFFECTED TEST STRIPS HAVE BEEN REQUESTED FOR RETURN.