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	03/28/2025
Type of Reportable Event	Malfunction
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
An advocate called on behalf of her husband to report that they ran a control test with the contour® next gen meter and obtained a reading of 156 mg/dl at 9:00 a.M.The meter did not automatically mark it as a control test, and so the reading will be displayed as a blood result when accessing the meter's memory.There was no allegation of an adverse event.The advocate was advised to return the device for evaluation.Replacement meter kit and test strips were sent to the customer.
Additional Manufacturer Narrative
Despite three follow-up attempts, the customer did not return the device for investigation.Therefore, an in-house testing was performed with the in-house contour® next gen meter with serial # (b)(6), in-house contour® next test strips from lot # 4gheg05a and in-house contour® next control solution from lot # 4bv2g3 in five replicates.All tests recovered within the expected control range of 112 mg/dl to 140 mg/dl.The control results obtained with the in-house testing were properly marked as control tests in the meter.The primary udi # has been corrected in section d4.

• 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: 21909251
• Report Number: 1810909-2025-00059
• Device Sequence Number: 17146046
• 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): 06/30/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/30/2025
• 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: 87 YR
• Patient Sex: Male