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

Model Number 7109B

Device Problem High Test Results (2457)

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

Event Date 03/19/2015

Event Type  malfunction  

Event Description

Customer alleged high readings using her contour meter.No adverse events alleged.The complaint did not meet the criteria to be reported at the time of the call, but the test strips and control solution were returned for evaluation.Replacement test strips, meter and control were sent to the customer.

Manufacturer Narrative

The control solution and test strips were returned for evaluation.One of five control tests gave a reading that was 63mg/dl high out of spec.The reading was not automatically marked as a control test by the meter, which will be displayed as a blood result when accessing the meter's memory.Satisfactory performance using retention strips.

• 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: 4681365
• MDR Text Key: 5688243
• Report Number: 1826988-2015-00139
• 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: 03/19/2015

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: 03/19/2015
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 04/10/2015
• 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