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

Model Number	7308
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record for contour next test strips lot # 9cpeg09a was reviewed and no anomalies were found.The maintenance log showed normal adjustments, and the vial line challenges and line clearance were successful.The patient/family was the initial reporter, so personal information was not entered.No information was captured as the customer's age and weight were not provided.
Event or Problem Description
The customer opened a box of contour next test strips and the bottle was already open.There was no allegation of an adverse event.The customer was advised to return the test strips for evaluation.Replacement test strips were sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour next test strips from lot # 9cpeg09a for evaluation.The contour next test strips user guide instructs the user to discard all test strips and not to use them if the cap is opened on a newly opened box of strips.The bottle of 50 contour next test strips arrived for investigation with only 25 strips in the bottle.In-house testing was performed using the returned test strips with in-house contour next one meter, which gave a 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: 9712546
• Report Number: 1810909-2020-00087
• Device Sequence Number: 19615183
• Product Code: NBW
• UDI-Device Identifier: 10301937308502
• UDI-Public: 10301937308502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111268
• 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): 01/22/2020

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: 03/31/2021
• Device Model Number: 7308
• Device Catalogue Number: 7308
• Device Lot Number: 9CPEG09A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1