CHEMSTRIP 10 URINE TEST STRIPS

Additional Manufacturer Narrative

SECTIONS D10 AND H3 WERE UPDATED. THE CUSTOMER'S STRIPS WERE RETURNED FOR INVESTIGATION. THE CUSTOMER'S TEST STRIPS WERE VISUALLY CHECKED AND THE STRIPS SHOWED SIGNS OF DISCOLORATION. DISCOLORATION OF TEST STRIPS IS INDICATIVE OF THE VIAL BEING LEFT OPEN TOO LONG. THE RETENTION MATERIAL OF LOT 41518000 WAS CHECKED BY VISUAL READING WITH A NITRITE-DILUTION-SERIES, A GLUCOSE-DILUTION-SERIES AND 0-NATIVE-URINE. THE RESULTS OF THE MEASUREMENTS OF THE RETENTION MATERIAL MEET SPECIFICATIONS. NO FALSE POSITIVE RESULTS WERE OBSERVED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). THE CUSTOMER'S TEST STRIPS HAVE BEEN REQUESTED FOR INVESTIGATION. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME. OCCUPATION IS LAY USER/PATIENT. ROUTINE RETENTION TESTING IS PERFORMED. RETENTION TESTING DATA IS REVIEWED AND APPROPRIATE ACTIONS ARE TAKEN AS NEEDED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE NITRITE AND GLUCOSE RESULTS USING CHEMSTRIP 10 URINE TEST STRIPS COMPARED TO A LABORATORY RESULT USING AN UNKNOWN METHOD. THE TEST STRIPS SHOWED A FALSE POSITIVE RESULT WITH A VISUAL READING. THE PATIENT QUESTIONED THE RESULT FROM THE TEST STRIPS AND CONSULTED A DOCTOR. THE LABORATORY RESULTS WERE NEGATIVE. THE LABORATORY RESULT WAS BELIEVED TO BE CORRECT.