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

Model Number 7109B

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem Hyperglycemia (1905)

Event Date 10/23/2015

Event Type  malfunction  

Event Description

The customer received high out of range control reading of 236 mg/dl on the contour meter.While checking the memory of the meter it was discovered that the reading was not automatically marked as a control test, which will be displayed as a blood result when accessing the meter's memory.No adverse event was alleged.Customer returned the control solution for evaluation.Replacement meter, strips and control were sent to the customer.

• Brand Name: CONTOUR
• Type of Device: QUALTIY 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: 5229536
• MDR Text Key: 31599681
• Report Number: 1826988-2015-00562
• 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: 10/23/2015

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: 01/31/2017
• Device Model Number: 7109B
• Device Lot Number: 3119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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