CONTOUR® NEXT
Received Feb 2, 2026 · Event occurred Jan 8, 2026
Report 1810909-2026-00005 · MDR key 24236185
Device
Generic name
Quality Control Material
Manufacturer
Ascensia Diabetes Care Us Inc.Model number
7314Catalog number
83624818
Lot number
5BV2G39
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
76 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER CONTACTED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT GEN METER, AS HE PERFORMED A CONTROL TEST AND THE READING WAS AUTOMATICALLY MARKED AS A BLOOD RESULT IN THE METER'S MEMORY. SINCE THE CUSTOMER USED INCORRECT TESTING TECHNIQUE, DURING TROUBLESHOOTING, ANOTHER CONTROL TEST WAS PERFORMED USING THE CORRECT TESTING TECHNIQUE AND A READING OF 130 MG/DL WAS OBTAINED. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL RESULT, 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. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.
Additional Manufacturer Narrative
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.