MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR® NEXT; QUALITY CONTROL MATERIAL

Model Number	7314
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted ascensia customer service to seek assistance with the contour® next gen meter.During the troubleshooting, two control tests were run and readings of 139 mg/dl and 194 mg/dl at 4:03 p.M.Were obtained.The meter did not automatically mark the control test of 194 mg/dl, and so the reading will be displayed as a blood result when accessing the meter's memory.The reading of 139 mg/dl was properly marked as a control result.There was no allegation of an adverse event.The customer was advised to return the device 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.
Additional Manufacturer Narrative
The customer returned the suspected contour® next gen meter (serial # (b)(6)), contour® next test strips (lot # 4lheg43a) and contour® next control solution (lot # 4bv2g31) for evaluation.An in-house testing was performed with the returned meter, test strips and control solution in two replicates, as only two strips were returned.Additionally, in-house testing was performed with returned meter, in-house contour® next test strips (lot # 4lheg43a) and returned control solution in five replicates.All tests recovered within the expected control range of 111 mg/dl to 138 mg/dl.The control results obtained with the in-house testing were properly marked as control tests in the meter.

• Brand Name: CONTOUR® NEXT
• Common Device Name: QUALITY CONTROL MATERIAL
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• Manufacturer (Section G): BIONOSTICS, INC. BUSINESS TRADE NAME: RNA MEDICAL; registration number: 1220649; 7 jackson rd.; devens MA 01434
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 22509351
• Report Number: 1810909-2025-00109
• Device Sequence Number: 21143986
• Product Code: JJX
• UDI-Device Identifier: 10301937314015
• UDI-Public: (01)10301937314015(17)260131(10)4BV2G31
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151742
• 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
• 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 Expiration Date: 01/31/2026
• Device Model Number: 7314
• Device Catalogue Number: 83624818
• Device Lot Number: 4BV2G31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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 Age: 68 YR
• Patient Sex: Male