MAUDE Adverse Event Report: LIFESCAN, INC. ONETOUCH ULTRA STRIPS; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2022

Event Type  Death  

Event Description

Patient is deceased.Unknown if patient was using strips at time of death.Pae reported by (b)(6) at hcp office.(b)(6) did consent to follow up.(b)(6).

• Brand Name: ONETOUCH ULTRA STRIPS
• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): LIFESCAN, INC.
• MDR Report Key: 16015415
• MDR Text Key: 305942256
• Report Number: MW5113855
• Device Sequence Number: 1
• Product Code: NBW
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 85 YR
• Patient Sex: Male