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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
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 sections a1 and a4 as the patient identifier 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 kit # associated with the meter is not available.If the information is available at the later date, it will be provided in the supplemental report, along with the udi number.
Event or Problem Description
The customer reported that one of her blood glucose readings was not stored in the memory of the contour® next one 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.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, a device history record was reviewed for the contour® next one meter, serial # (b)(6) associated with the event, and no manufacturing anomalies were found.Kit lot # and primary udi # for the contour® next one meter, serial # (b)(6) have been updated in section d4.

• 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): PT PHC INDONESIA (REGISTRATION #: 3009204541); kawasan industri mm2100; blok o-1; cikarang barat bekasi, jawa barat 17520 ; ID 17520
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 22906712
• Report Number: 1810909-2025-00126
• Device Sequence Number: 15437039
• Product Code: NBW
• UDI-Device Identifier: 00301937825019
• UDI-Public: (01)00301937825019(17)290531(10)PH24110014
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: PH24110014
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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 Age: 27 YR
• Patient Sex: Female