MAUDE Adverse Event Report: Ascensia Diabetes Care US Inc. Contour® Next; Blood Glucose Test Strips

Model Number	7312
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Hyperglycemia (1905); Confusion/ Disorientation (2553)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported obtaining the following blood glucose results using a contour® next link meter: 151 mg/dl at 5:38 p.M., 150 mg/dl at 5:50 p.M., 130 mg/dl at 6:08 p.M., and 93 mg/dl at 7:00 p.M.The customer also reported obtaining blood glucose results using a contour® next one meter of 107 mg/dl at 6:25 p.M., 92 mg/dl at 6:55 p.M., and 129 mg/dl at 7:08 p.M.The customer reported using both contour® next link and contour® next one meters with contour® next test strips from lots 4jheg01a and 4kheg01c.The customer was unable to determine which test strip lot or meter-strip combination was associated with any individual blood glucose result.Based on the reported glucose readings, the customer administered 4 units of insulin.The customer subsequently reported symptoms attributed to hyperglycemia, described as feeling "out of his mind," disoriented, and collapsing.The customer was admitted to a hospital for two days and was treated with insulin and his usual medications.Additional medication details and dosages were not provided.Following treatment, the customer recovered and was discharged from the hospital.The customer was advised to return the device for evaluation.Replacement meter kits were sent to the customer.
Additional Manufacturer Narrative
The device history records were reviewed for the suspected contour® next link (serial # (b)(6) and contour® next one (serial # (b)(6) meters, and no manufacturing anomalies were found.Additionally, the customer returned the contour® next link meter (serial # (b)(6), contour® next one (serial # (b)(6) meter and contour® next test strips (4jheg01a and 4kheg01c).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 event involved use of contour® next link and contour® next one meters in conjunction with contour® next test strips from lots 4jheg01a and 4kheg01c.The customer was unable to determine which meter-strip combination was associated with individual blood glucose results.Therefore, neither the specific meter system nor strip lot could be excluded as a potential contributor to the reported event.This mdr is submitted under 510(k) k160430.A separate mdr (1810909-2026-00057) has been submitted under 510(k) k160682 for the other potentially implicated system configuration.

• 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 791-0 395; JA 791-0395
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; +1(914)236-1830
• MDR Report Key: 50898500
• Report Number: 1810909-2026-00058
• Device Sequence Number: 12262349
• Product Code: NBW
• UDI-Device Identifier: 00301937312212
• UDI-Public: (01)00301937312212(17)261031(10)DW4KHEG01C
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 7312
• Device Catalogue Number: 83624788
• Device Lot Number: 4KHEG01C
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 76 YR
• Patient Sex: Male