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

Model Number 7325

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

Patient Problem No Information (3190)

Event Date 06/08/2015

Event Type  malfunction  

Event Description

During the call a (b)(6) customer received a control reading that was not automatically marked by the contour xt 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 was asked to return the control solution for investigation.New strips and control were sent to her.

Manufacturer Narrative

See remedial action and correction/removal reporting number.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): BAYER HEALTHCARE LLC; 430 s. beiger st.; mishawaka IN 46544
• Manufacturer Contact: jeri messmore ; 430 s. beiger st.; mishawaka, IN 46544 ; 5742567719
• MDR Report Key: 4910088
• MDR Text Key: 6834927
• Report Number: 1826988-2015-00333
• Device Sequence Number: 1
• Product Code: JJX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K111268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,consumer,foreign
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2016
• Device Model Number: 7325
• Device Lot Number: 3063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2482-2015
• Patient Sequence Number: 1