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

Model Number	7825
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer called ascensia customer service to seek assistance with her contour® next one meter.During the troubleshooting, it was found that one the customer's blood glucose readings was not stored in the meter's memory.The customer was experiencing symptoms of hyperglycemia, however, did not receive any treatment.There was no allegation of an adverse event.The device is not expected to be returned for evaluation.
Additional Manufacturer Narrative
The patient/family (a1) was the initial reporter (e1), so personal information was not entered.No information was captured in sections a2 and a4 as the customer's age and weight were not provided.The contour® next one 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.The customer requested follow-up call.Despite three follow-up attempts, the customer could not be reached.Therefore, the device is not expected to be returned for evaluation and a replacement meter kit could not be offered to the customer.
Additional Manufacturer Narrative
Despite three follow-up attempts, the customer did not return the device for evaluation.Therefore, a device history record was reviewed for the suspected contour® next one meter with serial # (b)(6), and no manufacturing anomalies were found.As per the initial report, the device manufacture date for contour® next one with serial # (b)(6) was captured as 28-jul-2022.The correct device manufacture date is 02-apr-2024.Section h4 has been updated with this information.

• Brand Name: CONTOUR® NEXT ONE
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• Manufacturer (Section G): PHC CORPORATION (REGISTRATION #: 3004167884); 110 oaza-inoshiri-aza-; nishiueno; wakimachi, mima tokusima 779-3 603; JA 779-3603
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 21504293
• Report Number: 1810909-2025-00026
• Device Sequence Number: 18144218
• Product Code: NBW
• UDI-Device Identifier: 00301937825019
• UDI-Public: (01)00301937825019(17)280930(10)DM02U166P
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210687
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 7825
• Device Catalogue Number: 90007939
• Device Lot Number: DM02U166P
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female