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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE INC. FREESTYLE FREEDOM LITE BLOOD MONITORING SYSTEM Back to Search Results
Model Number CEGS266-M6665
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.

 
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Brand NameFREESTYLE FREEDOM LITE BLOOD MONITORING SYSTEM
Type of DeviceFREESTYLE FREEDOM LITE BLOOD MONITORING SYSTEM
Manufacturer (Section F)
ABBOTT DIABETES CARE INC.
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
Device Event Key3621466
MDR Report Key3599331
Event Key3495866
Report NumberMW5034021
Device Sequence Number1
Product CodeNBW
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 Received01/23/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device MODEL NumberCEGS266-M6665
Device LOT NumberART20770 REV. A 08/10
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 01/23/2014 Patient Sequence Number: 1
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