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

Model Number	9740
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.Customer's weight was not provided.
Event or Problem Description
At 8:16 p.M., the customer performed blood glucose tests with the contour next link meter and a non-ascensia meter obtaining readings of 261 mg/dl and 119 mg/dl respectively.There was no allegation of an adverse event.The customer did not have any test strips left, therefore, the test strips are not expected to be returned.A replacement meter kit was sent to the customer.Since the strip information was not provided, this report will be submitted under the meter information.
Additional Manufacturer Narrative
The customer returned the suspected contour next link meter.No test strips were returned for evaluation.An in-house testing was performed using the returned meter with in-house contour next test strips, which gave satisfactory performance.

• 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: 9138682
• Report Number: 1810909-2019-00425
• Device Sequence Number: 2928822
• 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): 09/04/2019

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: 9740
• Device Catalogue Number: 9740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 10/01/2019
• 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: 54 YR