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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE FREESTYLE 14 DAY SENSORS SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE FREESTYLE 14 DAY SENSORS SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 190328Q
Device Problem Device Alarm System (1012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2019
Event Type  malfunction  
Event Description
The freestyle 14 day sensors have serious qa/qc issues. They typically are not reliable and do not perform as indicated. Errors in excess of 50+ units are not uncommon and errors in the 30+% range are often. If people use them to know when to take medicines or insulin they are likely overmedicating. I have months of data to support my claim and i am a chemical engineer by degree. Fda safety report id # (b)(4).
 
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Brand NameFREESTYLE 14 DAY SENSORS
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE
MDR Report Key9317071
MDR Text Key166737925
Report NumberMW5091034
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number190328Q
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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