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

Model Number	7309
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.
Event or Problem Description
The customer opened a box of contour next test strips and the bottle was already open.No adverse event was alleged.The customer was advised to return the strips for investigation.Replacement test strips were sent to the customer.

• Brand Name: CONTOUR NEXT
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 430 s beiger st; mishawaka IN 46544
• MDR Report Key: 7839448
• Report Number: 1826988-2018-00223
• Device Sequence Number: 1287406
• Product Code: NBW
• UDI-Device Identifier: 10301937309509
• UDI-Public: 10301937309509
• 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
• Report Date (Section B): 08/23/2018

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: 03/31/2020
• Device Model Number: 7309
• Device Catalogue Number: 7309
• Device Lot Number: 8CPEG09C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1