MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXT; QUALITY CONTROL MATERIAL

Model Number 7314

Device Problem Use of Incorrect Control/Treatment Settings (1126)

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

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address and phone were not provided.

Event Description

The advocate stated the customer ran a control test on the contour next link.The meter did not automatically mark it as a control test, which will be displayed as a blood result when accessing the meter's memory.No adverse event was alleged.The customer ended the call prematurely.Product was not replaced and not expected to be returned at the time of the call.

Manufacturer Narrative

This information was not provided in the initial report.

• Brand Name: CONTOUR NEXT
• Type of Device: QUALITY CONTROL MATERIAL
• 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 ; 5742567719
• MDR Report Key: 5537716
• MDR Text Key: 41826199
• Report Number: 1826988-2016-00133
• Device Sequence Number: 1
• Product Code: JJX
• Combination Product (y/n): N
• PMA/PMN Number: K110894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2017
• Device Model Number: 7314
• Device Lot Number: 3214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-2482-2015
• Patient Sequence Number: 1