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

Model Number	7825
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
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 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 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 from united kingdom reported that she bought the contour® next one meter from amazon and the meter was displaying the units of measurement accompanied with the blood glucose readings in mg/dl instead of mmol/l.The customer noticed the issue during the initial use of device and therefore, no blood glucose testing was performed.There was no allegation of an adverse event.The device is not expected to be returned for evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
The customer did not return the suspected device for evaluation.Therefore, the device history and distribution records were reviewed for the suspected contour® next one meter (serial # (b)(6)).It was found that the meter was programmed to display the units of measurement in mg/dl and was intended for, and distributed in, the us market.The meter was not configured for distribution in the uk market.The customer purchased the meter from amazon, which is not an authorized seller in the uk; therefore, it is likely that the issue occurred outside of ascensia's control.The kit lot # for the contour® next one meter (serial # (b)(6)) and the primary unique device identifier (udi) number 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: 22852053
• Report Number: 1810909-2025-00119
• Device Sequence Number: 4488818
• Product Code: NBW
• UDI-Device Identifier: 00301937825019
• UDI-Public: (01)00301937825019(17)290531(10)PH24110014
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: 07/21/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/08/2025
• 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 Sex: Female