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 12/01/2015

Event Type  malfunction  

Event Description

The customer received control results of 158,172 and 187mg/dl on the contour next usb.The meter did not automatically mark them as control tests, which will be displayed as blood results when accessing the meter's memory.No adverse event was alleged.Customer was advised to return the control solution for evaluation.New strips, meter and control were sent to the customer.

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: 5342008
• MDR Text Key: 35347119
• Report Number: 1826988-2015-00650
• Device Sequence Number: 1
• Product Code: JJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121087
• 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: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2016
• Device Model Number: 7314
• Device Lot Number: 3121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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