MAUDE Adverse Event Report: LIFESCAN SEATLAND LTD. ONE TOUCH ULTRA 2 ; GLUCOSE OXIDASE, GLUCOSE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 10/01/2017

Event Type  Injury  

Event Description

My blood glucose meter started acting up, giving me too high of readings, which consequently made me take extra insulin which wasn't needed.It's a one touch ultra which i'd had for about 4-5 years.(b)(6) and diabetics ought to change their blood glucose meters at least every 2 years not every 5 years which is the current practice.

• Brand Name: ONE TOUCH ULTRA 2
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): LIFESCAN SEATLAND LTD.
• MDR Report Key: 7316876
• MDR Text Key: 101832312
• Report Number: MW5075687
• 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: Patient
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 64 YR
• Patient Weight: 137