MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR; BLOOD GLUCOSE TEST STRIPS

Model Number 7097C

Device Problem Unsealed Device Packaging (1444)

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

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

Testing of the returned strips gave results of hi and e11 error code using control.The e11 error code and high result were most likely due to the strips being exposed to a moist environment due to the open cap of the bottle in the sealed box.The retention lot# gave satisfactory performance.

Event Description

The customer opened a box of contour test strips and the bottle was already open.No adverse event was alleged.The customer returned the strips for investigation, as exposure to moisture can cause high test results.Replacement test strips were sent to the customer.

• Brand Name: CONTOUR
• Type of Device: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 430 s. beiger st.; mishawaka IN 46544
• Manufacturer (Section G): ASCENSIA DIABETES CARE US INC.; 430 s. beiger st.; mishawaka IN 46544
• Manufacturer Contact: roger sonnenburg ; 430 s. beiger st.; mishawaka, IN 46544 ; 5742563441
• MDR Report Key: 5721176
• MDR Text Key: 47419977
• Report Number: 1826988-2016-00225
• Device Sequence Number: 1
• Product Code: NBW
• 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: 05/19/2016

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: 05/31/2017
• Device Model Number: 7097C
• Device Lot Number: 5EJ3C03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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