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

Model Number	9632
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained blood glucose readings of 41 and 241 mg/dl on a contour next link meter.The customer had no symptoms of hypoglycemia or hyperglycemia.There was no allegation of adverse event.The customer was advised to return the test strips for evaluation.A replacement meter was sent to the customer.Since the strip information was not provided, this report will be submitted under the meter information.

• Brand Name: CONTOUR NEXT EZ
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 8389624
• Report Number: 1810909-2019-00107
• Device Sequence Number: 19263404
• 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
• Report Date (Section B): 02/08/2019

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: 9632
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1