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

Lot Number 1036358

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem No Information (3190)

Event Date 01/30/2018

Event Type  malfunction  

Event Description

Test strips are not accurate; it is reported that they are over 10 points off.

Event Description

Test strips are not accurate; it is reported that they are over 10 points off.

• Brand Name: FREESTYLE LITE BLOOD GLUCOSE TEST STRIPS
• Type of Device: GLUCOSE DEHYDROGENASE, GLUCOSE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502
• MDR Report Key: 7295869
• MDR Text Key: 100936268
• Report Number: 7295869
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2019
• Device Lot Number: 1036358
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1