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

Model Number	7308
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.No information was captured, and the customer's age and weight were not provided.
Event or Problem Description
The customer reported that he obtained blood glucose readings of 387 mg/dl and 38 mg/dl at 4:28 a.M.On the contour next one meter.The customer experienced a symptom of hyperglycemia i.E.Frequent urination.There was no allegation of an adverse event.The device is not expected to be returned for evaluation.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, an in-house contour next one meter was tested with the in-house contour next test strips from lot # 9bpeg08b using a blood sample, which gave a satisfactory performance.

• 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
• MDR Report Key: 10643005
• Report Number: 1810909-2020-00526
• Device Sequence Number: 3650275
• Product Code: NBW
• UDI-Device Identifier: 10301937308502
• UDI-Public: 10301937308502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160682
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: 02/28/2021
• Device Model Number: 7308
• Device Catalogue Number: 7308
• Device Lot Number: 9BPEG08B
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1