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

Model Number	7278
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2020
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 two bottles of contour next test strips were already open.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement test strips were sent to the customer.
Additional Manufacturer Narrative
The manufacturing records were reviewed for the suspected contour next test strips from lot # 0bpec41a and no manufacturing anomalies were found.The process is designed so that the packaging cannot be performed if the lid is damaged or opened.

• 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
• MDR Report Key: 10384640
• Report Number: 1810909-2020-00395
• Device Sequence Number: 19536465
• Product Code: NBW
• UDI-Device Identifier: 10301937278706
• UDI-Public: 10301937278706
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

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 Expiration Date: 02/28/2022
• Device Model Number: 7278
• Device Catalogue Number: 7278
• Device Lot Number: 0BPEC41A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR