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

Model Number	7311
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
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 the customer to report that the customer performed blood glucose testing with the contour® next gen meter and obtained readings of lo (indicative of a reading below 20 mg/dl) at 9:02 am and 9:03 am, 55 mg/dl at 9:03 am, 97 mg/dl at 9:04 am, and another lo reading at 9:08 am.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 evaluation.Therefore, the in-house contour® next gen meter with (b)(6) and the in-house contour® next test strips from lot # 4bheg09a were used for in-house testing, using blood spiked with glucose at 134 mg/dl and 67 mg/dl, as determined by the ysi instrument in five replicates each.All tests recovered within the 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: 21652979
• Report Number: 1810909-2025-00050
• Device Sequence Number: 21159397
• Product Code: NBW
• UDI-Device Identifier: 00301937311505
• UDI-Public: (01)00301937311505(17)260228(10)DW4BHEG09A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223293
• 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): 06/05/2025

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: 02/28/2026
• Device Model Number: 7311
• Device Catalogue Number: 83624710
• Device Lot Number: 4BHEG09A
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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
• Patient Age: 55 YR
• Patient Sex: Female