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

Model Number 7309

Device Problems Display or Visual Feedback Problem (1184); Incorrect Measurement (1383); High Test Results (2457)

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

Event Date 09/01/2014

Event Type  malfunction  

Event Description

The customer received a high out of range control result of 170mg/dl on the contour next link meter.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.Control solution is to be returned for evaluation.New meter, strips and control were sent to the customer.

Manufacturer Narrative

The test strips were also returned for evaluation.Strip information was not included in the initial report.The customer control tested with customer strips gave two readings that were high out of spec by an average of 3mg/dl.Customer control tested with retention reagent gave two readings that were an average of 2mg/dl high out of spec.Retention control tested with customer strips gave one reading that was high out of spec by 1mg/dl.Retention reagent and retention control gave satisfactory performance.All control tests were marked as controls.

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: 4140593
• MDR Text Key: 4948343
• Report Number: 1826988-2014-00338
• Device Sequence Number: 1
• Product Code: JJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2014

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: 11/30/2015
• Device Model Number: 7309
• Device Lot Number: 3LFEF03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/08/2014
• Initial Date FDA Received: 10/03/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/21/2014; 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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