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

Model Number 7314

Device Problems Use of Incorrect Control/Treatment Settings (1126); Nonstandard Device (1420)

Patient Problem Hyperglycemia (1905)

Event Date 05/19/2017

Event Type  malfunction  

Event Description

The customer received a control reading of 177mg/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.The control was not expected to be returned for investigation.New meter, strips and control were sent to the customer.

• Brand Name: CONTOUR NEXT
• Type of Device: QUALITY CONTROL MATIERAL
• 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: 6633130
• MDR Text Key: 77504519
• Report Number: 1826988-2017-00187
• 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
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/19/2017
• Device Model Number: 7314
• Device Lot Number: 6BV2403
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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