MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXT EZ; BLOOD GLUCOSE METER

Device Problem Invalid Sensing (2293)

Patient Problem Hyperglycemia (1905)

Event Date 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

The call ended before the customer's personal information or product information could be obtained.It's not possible to determine the manufacture date without the product information.

Event Description

Paramedic stated they received a blood glucose reading of 25mg/dl on the contour next ez, retested the patient on two other meters and the readings were both 204mg/dl.The difference between the readings falls in the "c" zone of the consensus error grid, making the difference clinically significant.No adverse event was alleged.Further information was not provided.Product was not expected to be returned, and was not replaced.

• Brand Name: CONTOUR NEXT EZ
• Type of Device: BLOOD GLUCOSE METER
• 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: 6539820
• MDR Text Key: 74414747
• Report Number: 1826988-2017-00142
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K111268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1