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

Model Number 7312

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

The patient was the initial reporter, so personal information was not entered.

Event 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
• Type of Device: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC; 430 s beiger st; mishawaka IN 46544
• Manufacturer (Section G): ASCENSIA DIABETES CARE US INC; 430 s beiger st; mishawaka IN 46544
• Manufacturer Contact: jeri messmore ; 430 s beiger st; mishawaka, IN 46544 ; 5743149617
• MDR Report Key: 6820105
• MDR Text Key: 83647497
• Report Number: 1826988-2017-00274
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 10301937312219
• UDI-Public: 10301937312219
• Combination Product (y/n): N
• PMA/PMN Number: K111268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/03/2017

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Model Number: 7312
• Device Lot Number: 6GFEF08B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2017
• Initial Date FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1