FDA Adverse Event Malfunction Summary report: N

CONTOUR® NEXT

MDR report key: 24277867 · Received February 6, 2026

Report

Report Number: 1810909-2026-00006
Event Type: Malfunction
Date Received: February 6, 2026
Date of Event: January 12, 2026
Report Date: February 6, 2026
Manufacturer: ASCENSIA DIABETES CARE US INC.
Product Code: NBW
UDI-DI: 65016003790317
PMA / PMN Number: K223293
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PT
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. THEREFORE, A DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR® NEXT METER, SERIAL # (B)(6) AND NO MANUFACTURING ANOMALIES WERE FOUND. THE CONTOUR® NEXT METER DOES NOT HAVE AN EXPIRATION DATE. THEREFORE, NO INFORMATION WAS CAPTURED IN SECTION D4 (EXPIRATION DATE). THE WARRANTY PERIOD OF THE METER IS 5 YEARS FROM THE DATE OF THE ORIGINAL PURCHASE. CONTOUR® NEXT METER IS SIMILAR TO THE CONTOUR® NEXT GEN METER AVAILABLE IN US MARKET. THEREFORE, PRODUCT CODE NBW AND 510 (K) # K223293 ASSOCIATED WITH THE CONTOUR® NEXT GEN METER MARKETED IN US WERE CAPTURED IN SECTIONS D2B AND G4 RESPECTIVELY. CONTOUR® NEXT METER WITH SKU # 7903E AND UDI # (B)(4) WAS DISTRIBUTED OUTSIDE OF THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

Description of Event or Problem · 0

THE CUSTOMER FROM PORTUGAL REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR® NEXT METER. 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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
338793	CONTOUR® NEXT	BLOOD GLUCOSE METER	NBW	ASCENSIA DIABETES CARE US INC.	7903E	DP01U338P	65016003790317

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Male