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

Model Number	7309
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	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.The customer's weight was not provided.
Event or Problem Description
The customer obtained blood glucose readings of 331 mg/dl and 69 mg/dl on a contour next link 2.4 meter at 2:21 p.M.And 2:29 p.M.Respectively.There was no allegation of an adverse event.Since the customer used all the test strips from the affected vial, no test strips are expected to be returned.A replacement meter was sent to the customer.
Additional Manufacturer Narrative
The customer only returned the contour next link 2.4 meter.The serial number of the returned meter was different from the one they alleged obtaining inaccurate readings on.The customer's returned meter was tested with in-house contour next test strips from lot # 8kpeg12c and in-house contour next control solution from lot # 9bv2g39, which gave satisfactory performance.

• Brand Name: CONTOUR NEXT
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 8486342
• Report Number: 1810909-2019-00164
• Device Sequence Number: 11244805
• Product Code: NBW
• UDI-Device Identifier: 10301937309509
• UDI-Public: 10301937309509
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150001
• 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): 03/29/2019

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 Expiration Date: 10/31/2020
• Device Model Number: 7309
• Device Catalogue Number: 7309
• Device Lot Number: 8KPEG12C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR