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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE INC. ABBOTT FREESTYLE LIBRE SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Abscess (1690); Erythema (1840); Pain (1994); Patient Problem/Medical Problem (2688)
Event Date 08/01/2018
Event Type  Injury  
Event Description
Abbott freestyle libre. Infected filament probes? first sensor had no problems, no serial number. Second sensor problems as hereunder serial number. Third sensor problems as hereunder serial number. There was no problem from adhesive area. The area of insertion point of filament probe developed following. I have photos if needed, erythema of skin, firm 2-3 mm nodule at insertion point -abscess like features at skin surface; warm surrounding skin; -2 to 3 cm firm nodule in skin; painful to light touch; pain so significant that at night i elevated arm on another pillow so that area should not touch bed. First instance skin nodule still 30% despite fluocinonide cream and neosporin. (about 10 days) - second instance skin nodule still 70% despite medicine as above. First time, after shower, skin was thoroughly cleaned with both provided alcohol pads. Second time, during shower, skin was cleaned with soap. Hibiclens, betadine. Then cleaned with provided alcohol pads. Possible infected filament probes? allergic reaction to filament probe?.
 
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Brand NameABBOTT FREESTYLE LIBRE SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key7776705
MDR Text Key117019801
Report NumberMW5079070
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
Type of Report Initial
Report Date 08/09/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/10/2018 Patient Sequence Number: 1
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