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

Model Number	7818
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2019
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 as the customer's weight was not provided.
Event or Problem Description
The customer reported that since (b)(6) 2019 her blood glucose readings were not being stored in the memory of the contour next one meter.There was no allegation of an adverse event.The customer was advised to return the meter for evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour next one meter (serial # (b)(6)) for evaluation.An in-house testing was performed using the returned meter with in-house contour next control solution and in-house contour next test strips, which gave satisfactory performance.Additionally, simulated blood tests were performed with the returned meter.All readings were within specifications and properly stored in meter's memory.Section d4 of the initial report indicated serial # of the affected meter as (b)(6).Based on the clarification received, serial # for the affected meter is (b)(6).Serial # in section d4 and device manufacture date in section h4 have been updated.

• Brand Name: CONTOUR NEXT ONE
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 9376816
• Report Number: 1810909-2019-00530
• Device Sequence Number: 3103624
• Product Code: NBW
• UDI-Device Identifier: 00301937818011
• UDI-Public: 00301937818011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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 Model Number: 7818
• Device Catalogue Number: 7818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR