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

Model Number	9632
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2020
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 he was in a nursing facility when he performed comparison testing between his two contour next link meters and the nursing facility's meter.The customer stated that blood glucose readings on both the contour next link meters were 20 to 50 mg/dl higher compared to that obtained on the nursing facility's meter.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.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 did not return the product for evaluation.A device history record was reviewed for the suspected contour next link meter and no manufacturing anomalies were found.The device manufacture date in section h4 of the initial report was captured as 08-sep-2015.The correct device manufacture date is 09-sep-2015.Section h4 has been updated with this information.

• 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
• MDR Report Key: 9819245
• Report Number: 1810909-2020-00130
• Device Sequence Number: 11522339
• 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): 02/16/2020

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: 9632
• Device Catalogue Number: 9632
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR