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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE; SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Inflammation (1932); Irritation (1941); Rash (2033)
Event Date 07/20/2019
Event Type  Injury  
Event Description
I have been using freestyle libre continuous glucose monitoring device since (b)(6) 2019.Around (b)(6), i felt irritation at the sensor site i.E., my right hand - upper back side, and when i removed the sensor i found a red rash on the site.I started a new sensor on my left hand, but after 7-8 days i felt a similar irritation and removed the sensor immediately.I found a more severe rash on the left hand.It is now (b)(6) and my rashes have not healed yet.I had to switch to finger stick testing, and also saw my physician who has now prescribed me with oral steroids, and topical steroids to suppress inflammation.He believes dermatitis and erythema are due to the glue used in the sensor that makes it stick to the skin for 14 days.If the fda needs more info, i will be happy to provide it.Fda safety report id# (b)(4).
 
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Brand Name
FREESTYLE LIBRE
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE, INC.
MDR Report Key8901334
MDR Text Key154722116
Report NumberMW5089075
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/13/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/15/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age47 YR
Patient Weight87
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