MAUDE Adverse Event Report: LIFESCAN INC. ONE TOUCH TEST STRIPS; GLUCOSE OXIDASE, GLUCOSE

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Death  

Event Description

Patient was using when they expired.

• Brand Name: ONE TOUCH TEST STRIPS
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): LIFESCAN INC.
• MDR Report Key: 15536635
• MDR Text Key: 301160765
• Report Number: MW5112379
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male