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

Model Number	7824
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the covid-19 pandemic, the investigation for this event will be delayed.We will however, send the follow-up report as soon as our laboratory services are able to return to normal.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.This event is related to mdr # 1810909-2020-00201.
Event or Problem Description
The customer reported that one of her blood glucose readings was 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 device for evaluation.Replacement meter and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer did not return the suspected contour next one meter for evaluation.Therefore, a device history record was reviewed for the suspected meter and no manufacturing anomalies were found.
Additional Manufacturer Narrative
The customer returned the suspected contour next one meter for evaluation.No test strips were returned.Therefore, the in-house contour next test strips were used for testing.The returned meter was tested with the in-house test strips and in-house contour next control solution, which gave a satisfactory performance.The returned meter was then tested with the in-house test strips and in-house breeze2 control solution to simulate blood, which gave a satisfactory performance.The returned meter was also tested with the in-house test strips using a blood sample, which gave a satisfactory performance.All blood glucose readings obtained during in-house testing were properly stored in the meter's memory.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, the in-house contour next one meter was tested with the in-house contour next test strips, which gave a satisfactory performance.All blood glucose readings obtained during in-house testing were properly stored in the meter's memory.

• 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
• MDR Report Key: 9977161
• Report Number: 1810909-2020-00202
• Device Sequence Number: 2248143
• Product Code: NBW
• UDI-Device Identifier: 00301937824012
• UDI-Public: 00301937824012
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/25/2020

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 Model Number: 7824
• Device Catalogue Number: 7824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 07/17/2020; 08/27/2020; 10/08/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 07/17/2020; 09/01/2020; 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR