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

Model Number	7252
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information was captured, as the contact information of the primary reporter (pharmacist) was not provided.No information was captured as the customer's age and weight were not provided.
Event or Problem Description
A pharmacist called on behalf of the customer to report that the customer's blood glucose readings were not being stored in the memory of the contour next ez meter.There were no readings in the meter's memory.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 ez meter was tested with the in-house contour next 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.Additionally, a device history record was reviewed for the suspected contour next ez meter and no manufacturing anomalies were found.

• Brand Name: CONTOUR NEXT EZ
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla, ny
• MDR Report Key: 9775647
• Report Number: 1810909-2020-00108
• Device Sequence Number: 2185423
• Product Code: NBW
• UDI-Device Identifier: 00301937252013
• UDI-Public: 00301937252013
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111268
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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 Model Number: 7252
• Device Catalogue Number: 7252
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1