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

Model Number	9632
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.Sections were left blank as the customer's age and weight are unknown.
Event or Problem Description
The advocate of the customer reported that the blood glucose readings were not being stored in the memory of the contour next link meter.No adverse event alleged.The customer was advised to return the meter for evaluation.Replacement meter was sent to the customer.
Additional Manufacturer Narrative
The customer's returned meter was tested with in-house test strips lot # 8bpeg01b since both vials of returned contour next strips were expired jul-2018 (lot 6gfeg03c).The returned contour next control solution was also expired jan-2014 and could not be tested.All results with the in-house strips and returned meter were within expected ranges and properly stored in meter's memory.Additionally, all results were still observed in the meter's memory (with the exception of 264 mg/dl taken on (b)(6) 2018 at 8:00 p.M.Which was observed to be 274 mg/dl and 224 mg/dl taken on (b)(6) 2017 at 10:20 a.M.Which was observed to be 234 mg/dl).It is important to note that expired products should not be used for testing to attain accurate blood glucose results.

• 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: 7868343
• Report Number: 1810909-2018-00007
• Device Sequence Number: 1566997
• Product Code: NBW
• UDI-Device Identifier: 00301939632011
• UDI-Public: 00301939632011
• 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): 08/17/2018

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: 9632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1