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

Model Number	7277
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the bottle of contour next test strips was already open.There was no allegation of an adverse event.The customer returned the bottle of test strips to pharmacy from where she purchased the bottle of test strips.Therefore, the bottle of test strips is not expected to be returned.Replacement test strips were sent to the customer.
Additional Manufacturer Narrative
A device history record was reviewed for the suspected contour next test strips lot # 9dpec41a and no anomalies were found.The work order was run on the auto line, which had a vision inspection for open caps.A line challenge was completed on every shift, and the open lid challenge on each shift passed, signifying that the vision inspection system was working correctly.The packaging was potentially tampered after it left ascensia' s control.The customer claims to have returned the vial to the pharmacy but was able to take pictures prior, showing a vial with a closed cap, no damaged carton and a vial with blood stains indicating it had been used.

• 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: 10128831
• Report Number: 1810909-2020-00291
• Device Sequence Number: 19374109
• Product Code: NBW
• UDI-Device Identifier: 10301937277358
• UDI-Public: 10301937277358
• 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): 05/12/2020

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: 04/30/2021
• Device Model Number: 7277
• Device Catalogue Number: 7277
• Device Lot Number: 9DPEC41A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1