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

Model Number	9763
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Fever (1858); Pain (1994)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient/family (a1) was the initial reporter (e1), so personal information was not entered.No information was captured in section 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.
Event or Problem Description
An advocate called to report that the customer obtained a blood glucose reading of 300 mg/dl with the contour® next one meter.The customer took 5 units of insulin based on the meter's readings.The customer was experiencing symptoms such as body ache and fever.Since the customer was not feeling well even after taking insulin, she went to the hospital where a reading of 153 mg/dl was obtained with the hospital's meter.The customer was given fluids in the hospital.A few hours later, a laboratory testing was performed and a reading of 163 mg/dl was obtained.No further event details were provided.The customer disconnected the call.Therefore, a replacement device could not be offered and the device could not be requested back for evaluation.Since the strip information was not provided, this report will be submitted under the meter information.
Additional Manufacturer Narrative
Despite the 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.

• 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 NUMBER: 3009204541); kawasan industri mm2100 blok o; cikarang barat bekasi; jawa barat, 17520 ; ID 17520
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 21504834
• Report Number: 1810909-2025-00034
• Device Sequence Number: 14552961
• Product Code: NBW
• UDI-Device Identifier: 00301939763012
• UDI-Public: (01)00301939763012(17)180831(10)DW04L116P
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 9763
• Device Catalogue Number: 85012088
• Device Lot Number: DW04L116P
• 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: 02/06/2025
• 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: 12/13/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female