MAUDE Adverse Event Report: BAYER HEALTHCARE LLC CONTOUR NEXT; QUALITY CONTROL MATERIAL

Model Number 7314

Device Problem High Test Results (2457)

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

Event Date 01/13/2014

Event Type  malfunction  

Event Description

The customer called for assistance with his meter and during the call he received a high out of range control result of 194 mg/dl on his contour next ez 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.He is expected to return the control solution for evaluation.A new meter, strips and control were sent to him.

• Brand Name: CONTOUR NEXT
• Type of Device: QUALITY CONTROL MATERIAL
• Manufacturer (Section D): BAYER HEALTHCARE LLC; 430 s. beiger st.; mishawaka IN 46544
• Manufacturer (Section G): BAYER HEALTHCARE LLC; 430 s. beiger st.; mishawaka IN 46544
• Manufacturer Contact: roger sonnenburg ; 430 w. beiger st.; mishawaka, IN 46544 ; 5742563441
• MDR Report Key: 3593805
• MDR Text Key: 4168366
• Report Number: 1826988-2014-00015
• Device Sequence Number: 1
• Product Code: JJX
• 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: 01/13/2014

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: 01/31/2014
• Device Model Number: 7314
• Device Lot Number: 2485
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2014
• Initial Date FDA Received: 01/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1