MAUDE Adverse Event Report: BAYER HEALTHCARE LLC CONTOUR NEXT; BLOOD GLUCOSE TEST STRIPS

Model Number 7313

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Shelf Life Exceeded (1567)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

The returned contour control was tested with in-house contour next test strips.The readings were an average of 160mg/dl high out of the range.The readings were not marked as control tests.The same strips were tested with the correct in-house control, contour next, and gave satisfactory performance.

Event Description

The customer ran tests on the contour next usb with contour control solution and expired contour next test strips.The results were 303 and 341mg/dl.The meter did not automatically mark the readings as control tests, which will be displayed as blood results when accessing the meter's memory.No adverse event was alleged.Customer was advised to return the strips for investigation.New meter, strips and control were sent to the customer.

• Brand Name: CONTOUR NEXT
• Type of Device: BLOOD GLUCOSE TEST STRIPS
• 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: 5149833
• MDR Text Key: 28518766
• Report Number: 1826988-2015-00514
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2015
• Device Model Number: 7313
• Device Lot Number: 3DFEC52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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