MAUDE Adverse Event Report: BAYER CONTOUR METER; GLUCOSE OXIDASE, GLUCOSE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

The customer reported he had just been released from hospital following an incident of hyperglycemia.He stated he was not able to test prior to incident as the contour meter he had been using was not working.The contour meter mentioned in this event is not manufactured or imported by our firm.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CONTOUR METER
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): BAYER
• MDR Report Key: 17536943
• MDR Text Key: 321153269
• Report Number: MW5143826
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2013

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1