MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR® NEXT; BLOOD GLUCOSE TEST STRIPS

Model Number	7277
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer opened a box of contour® next test strips and found that the bottle was already open.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement test strips were sent to the customer.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, the device history record was reviewed for the suspected contour® next test strips for lot # 5bhec41a, which showed that the cap on the test strip vial was sealed.As per the historical review of the event for the similar issues, modifications were made to the carton dimensions to help prevent vial caps from opening after packaging.

• 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 ehime, 791-0 395; JA 791-0395
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 23038436
• Report Number: 1810909-2025-00142
• Device Sequence Number: 9889387
• Product Code: NBW
• UDI-Device Identifier: 10301937277358
• UDI-Public: (01)10301937277358(17)270228(10)DW5BHEC41A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K241787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 7277
• Device Catalogue Number: 85723154
• Device Lot Number: 5BHEC41A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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
• Patient Age: 56 YR
• Patient Sex: Male