MAUDE Adverse Event Report: Ascensia Diabetes Care US Inc. Contour® Next; Blood Glucose Test Strips

Model Number	7312
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Hyperglycemia (1905); Confusion/ Disorientation (2553)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury

• Brand Name: Contour® Next
• Common Device Name: Blood Glucose Test Strips
• Manufacturer (Section D): Ascensia Diabetes Care US Inc.; 100 summit lake drive; valhalla NY 10595
• Manufacturer (Section G): PHC Corporation (Registration Number: 1000134386); 2131-1 minamigata; toon 791-0 395; JA 791-0395
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; +1(914)236-1830
• MDR Report Key: 50898428
• Report Number: 1810909-2026-00057
• Device Sequence Number: 10711784
• Product Code: NBW
• UDI-Device Identifier: 00301937312212
• UDI-Public: (01)00301937312212(17)260930(10)DW4JHEG01A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2026
• Device Model Number: 7312
• Device Catalogue Number: 83624788
• Device Lot Number: 4JHEG01A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male