MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE FREEDOM LITE BLOOD MONITORING SYSTEM

Model Number CEGS266-M6665

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2014

Event Type  malfunction  

Event Description

Abbott freestyle lite blood glucose test strips lot number: 1378940, date: 04/2015.This container of strips gave reading between 58 and 132 within a 5 minute period.This could not be the case that my husband's blood sugar would change like this.He does not use insulin.This is not a lot that has been recalled.It has been pretty constant over the past few months that he has to take a reading four times in the morning to get some readings that are close.When i have called the company in the past, we are told it is normal to have readings vary by 20%.This is not reasonable.Please help the company to take the steps to have more accurate test strips.They are expensive.The strips from this container have all been used.

• Brand Name: FREESTYLE FREEDOM LITE BLOOD MONITORING SYSTEM
• Type of Device: FREESTYLE FREEDOM LITE BLOOD MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 3599331
• MDR Text Key: 4067508
• Report Number: MW5034021
• Device Sequence Number: 1
• Product Code: NBW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CEGS266-M6665
• Device Lot Number: ART20770 REV. A 08/10
• Patient Sequence Number: 1
• Patient Age: 66 YR