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 01/05/2017

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

The customer returned the bottle of strips for qa.They gave e11 using control.Four of five blood results averaged 5mg/dl high out of spec using blood.E11 indicates exposure to moisture which usually causes high results.Retention reagent gave satisfactory performance.

• 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: jeri messmore ; 430 s. beiger st.; mishawaka, IN 46544 ; 5742567719
• MDR Report Key: 6278830
• MDR Text Key: 66043386
• Report Number: 1826988-2017-00005
• 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,Followup
• Report Date: 01/05/2017

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: 11/30/2017
• Device Model Number: 7097C
• Device Lot Number: 5LJ3D02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 01/26/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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