CONTOUR® NEXT

Additional Manufacturer Narrative

THE CUSTOMER RETURNED THE SUSPECTED CONTOUR® NEXT GEN METER (SERIAL # (B)(6)) AND CONTOUR® NEXT TEST STRIPS (LOT # 5BHEG08A) FOR EVALUATION. NO CONTROL SOLUTION WAS RETURNED. THEREFORE, AN IN-HOUSE TESTING WAS PERFORMED WITH THE RETURNED METER, RETURNED TEST STRIPS AND IN-HOUSE CONTOUR® NEXT CONTROL SOLUTION (LOT # 5BV2G40) IN FIVE REPLICATES. ALL TESTS RECOVERED WITHIN THE EXPECTED CONTROL RANGE OF 110 MG/DL TO 138 MG/DL. THE CONTROL RESULTS OBTAINED WITH THE IN-HOUSE TESTING WERE PROPERLY MARKED AS CONTROL TESTS IN THE METER. THE PATIENT/FAMILY (A1) WAS THE INITIAL REPORTER (E1), SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED IN SECTION A4 AS THE CUSTOMER'S WEIGHT WAS NOT PROVIDED.

Description of Event or Problem

THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT GEN METER. DURING TROUBLESHOOTING, A CONTROL TEST WAS RUN AND A READING OF 196 MG/DL WAS OBTAINED. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER¿S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.