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

Model Number 7252

Device Problems Data Back-Up Problem (2902); Loss of Data (2903); Patient Data Problem (3197)

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

Event Date 01/13/2017

Event Type  malfunction  

Event Description

The customer stated her blood glucose reading was not stored in the memory of the contour next ez.No adverse event alleged.The customer was asked to return the meter for investigation.A replacement meter was sent to her.

• 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 ; 5742563441
• MDR Report Key: 6292588
• MDR Text Key: 66500395
• Report Number: 1826988-2017-00017
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111268
• 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: 01/13/2017

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 Model Number: 7252
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2017
• Initial Date FDA Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2012
• 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