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

Model Number	7278
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Weakness (2145); Dizziness (2194)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained following blood glucose readings between 6:17 p.M.And 6:27 p.M.On her contour next link 2.4 meter: 517 mg/dl, 561 mg/dl, 148 mg/dl, 126 mg/dl, and 59 mg/dl.The customer stated that she was experiencing hypoglycemic symptoms such as dizziness and weakness.The customer drank apple juice.There was no allegation of an adverse event.The customer was advised to return the test strips for evaluation.Replacement meter and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer did not return the suspected product.The in-house contour next link 2.4 meter was tested with the in-house contour next test strips from lot # 8jpec42c, 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: 8612857
• Report Number: 1810909-2019-00211
• Device Sequence Number: 14071579
• Product Code: NBW
• UDI-Device Identifier: 10301937278706
• UDI-Public: 10301937278706
• Combination Product (Y/N): N
• 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): 04/25/2019

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: 09/30/2020
• Device Model Number: 7278
• Device Catalogue Number: 7278
• Device Lot Number: 8JPEC42C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 YR