MAUDE Adverse Event Report: BAYER / Ascensia DIABETES CARE INC. CONTOUR NEXT TEST STRIPS; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Type  No Answer Provided  

Event Description

Bayer contour next test strips / bayer contour test strips pt's caregiver requested the incorrect brand of test strips, which were dispensed.Pt was unable to use in his meter.Reassigned prescription for remaining refills.(b)(6).

• Brand Name: CONTOUR NEXT TEST STRIPS
• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): BAYER / Ascensia DIABETES CARE INC.
• MDR Report Key: 12217575
• MDR Text Key: 263473684
• Report Number: MW5102737
• Device Sequence Number: 1
• Product Code: NBW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 07/22/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1