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

Model Number 7111B

Device Problems High Test Results (2457); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/17/2016

Event Type  malfunction  

Event Description

A healthcare professional ran the high control solution on the contour and received a result of hi.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 was advised to return the control for evaluation.New strips, meter and control were sent to the customer.

• Brand Name: CONTOUR
• 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: 6046298
• MDR Text Key: 58464819
• Report Number: 1826988-2016-00408
• Device Sequence Number: 1
• Product Code: JJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/17/2016

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: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 7111B
• Device Lot Number: 3272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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