MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. ABBOTT FREESTYLE LITE STRIPS; GLUCOSE DEHYDROGENASE GLUCOSE

Model Number FREE STYLE LITE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 08/01/2018

Event Type  malfunction  

Event Description

My glucose blood monitoring strips do not work.They do not absorb the blood.I have been testing them for over a week, and they still do not work.Product: abbott freestyle lite strips list no: 71026-70, ndc: (b)(4), lot: 1049963 2020-04-30, code:16.

• Brand Name: ABBOTT FREESTYLE LITE STRIPS
• Type of Device: GLUCOSE DEHYDROGENASE GLUCOSE
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 7780302
• MDR Text Key: 117257472
• Report Number: MW5079112
• Device Sequence Number: 1
• Product Code: LFR
• 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: 08/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FREE STYLE LITE
• Device Catalogue Number: 71026-70
• Device Lot Number: 1049963
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 94