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

Model Number	9740
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient was also the initial reporter.Personal information was not entered.
Event or Problem Description
The customer initially called for assistance with high readings.During the call she was unable to see her blood glucose readings in the memory of the contour next link.The readings were from the previous week.No adverse event was alleged.The customer was advised to return the meter for evaluation.A new meter was sent to her.
Additional Manufacturer Narrative
The number of tests run in the returned meter indicated 1, which was recorded in the memory as 246mg/dl.The customer had indicated the test run at that time was 164mg/dl.It may be possible the customer had more than one meter and was confused on which meter the tests were run.

• Brand Name: CONTOUR NEXT LINK
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC; 430 s beiger st; mishawaka IN 46544
• MDR Report Key: 7312576
• Report Number: 1826988-2018-00033
• Device Sequence Number: 11176612
• Product Code: NBW
• UDI-Device Identifier: 00301939740013
• UDI-Public: 00301939740013
• 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): 02/13/2018

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: 9740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 03/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1