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

Model Number	7278
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	09/17/2025
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 a4 as the customer's weight was not provided.
Event or Problem Description
The customer reported obtaining a high blood glucose reading using the contour® next ez meter.Based on this reading, the customer administered additional insulin.Approximately two hours later, the customer began experiencing symptoms of hypoglycemia, which he described as feeling dizzy.He could not recall the exact glucose value that prompted the additional insulin dose.The customer stated that the event occurred after he had eaten a meal and gone for a walk.He subsequently contacted emergency services and was transported to the hospital.At the hospital, a blood glucose test revealed a reading of 46 mg/dl.The customer ate 5 pretzels and was treated with glucose and recovered well.He remained in the hospital for approximately three hours.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.
Event or Problem Description
The customer returned the suspected contour® next ez meter for evaluation.A review of the meter's logbook showed the following blood glucose readings recorded on the date of the event (b)(6) 2025): 171 mg/dl at 11:27 a.M., 115 mg/dl at 12:25 p.M., 43 mg/dl at 1:37 p.M., 110 mg/dl at 7:59 p.M., 86 mg/dl at 9:08 p.M., and 60 mg/dl at 11:29 p.M.
Additional Manufacturer Narrative
The customer returned the suspected contour® next ez meter (serial # (b)(6)) for evaluation.No test strips were returned.An in-house testing was performed with the returned meter and in-house contour® next test strips (lot # 4kheg43a) using blood spiked with glucose at 68 mg/dl, as determined by ysi instrument in five replicates.All tests recovered within fit-for-use limits.

• Brand Name: CONTOUR® NEXT
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• Manufacturer (Section G): PHC CORPORATION (REGISTRATION NUMBER: 1000134386); 2131-1 minamigata; toon ehime, 791-0 395; JA 791-0395
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 23324187
• Report Number: 1810909-2025-00155
• Device Sequence Number: 10637989
• Product Code: NBW
• UDI-Device Identifier: 10301937278706
• UDI-Public: (01)10301937278706(17)261031(10)DW4KHEG43A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191286
• 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,Followup
• Report Date (Section B): 12/19/2025

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: 7278
• Device Catalogue Number: 85701231
• Device Lot Number: 4KHEG43A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 11/04/2025; 12/10/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/04/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male