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

Model Number	6203
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2019
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 her blood glucose readings were not being stored in the memory of the contour next link meter.There was no allegation of an adverse event.The customer was advised to return the meter for evaluation.Replacement meter and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer did not return the suspected product for evaluation.An in-house testing was performed using the in-house contour next link meter with in-house contour next test strips, which gave satisfactory performance.All 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 link meter and no manufacturing anomalies were found.

• Brand Name: CONTOUR NEXT LINK
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 8916512
• Report Number: 1810909-2019-00358
• Device Sequence Number: 11262685
• Product Code: NBW
• UDI-Device Identifier: 00301936203016
• UDI-Public: 00301936203016
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110894
• 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): 07/25/2019

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: 6203
• Device Catalogue Number: 6203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 10/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR