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

Model Number	9763
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from united kingdom (uk) reported that the contour® next one meter purchased in uk from amazon website was displaying the units of measurement accompanied with the blood glucose readings in mg/dl instead of mmol/l.There was no allegation of an adverse event.The customer returned the suspected device to amazon.Therefore, the device is not expected to be returned for evaluation.A replacement meter kit was sent to the customer.
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.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.
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 with 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 to be distributed in the uk market.The issue occurred outside of ascensia's control.Section g1 (continued) - manufacturing site for device information has been corrected.The device manufacture date in section h4 has been updated.

• 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: 21777428
• Report Number: 1810909-2025-00056
• Device Sequence Number: 8829291
• Product Code: NBW
• UDI-Device Identifier: 00301939763012
• UDI-Public: (01)00301939763012(17)210131(10)DW02N273P
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160682
• 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): 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: 9763
• Device Catalogue Number: 85012088
• Device Lot Number: DW02N273P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female