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

Model Number 7109B

Device Problems Display or Visual Feedback Problem (1184); High Test Results (2457); Device Operates Differently Than Expected (2913)

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

Event Date 09/01/2014

Event Type  malfunction  

Event Description

The customer received a high out of range control result of 183mg/dl on the contour 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.Control solution was returned for evaluation.New strips and control were sent to the customer.

• Brand Name: CONTOUR
• 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 s. beiger st.; mishawaka, IN 46544 ; 5742563441
• MDR Report Key: 4166995
• MDR Text Key: 4874228
• Report Number: 1826988-2014-00348
• 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: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/15/2014

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: 03/31/2016
• Device Model Number: 7109B
• Device Lot Number: 2989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2014
• Initial Date Manufacturer Received: 09/15/2014
• Initial Date FDA Received: 10/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1