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

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?.

• Brand Name: ABBOTT FREESTYLE LIBRE SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 7776705
• MDR Text Key: 117019801
• Report Number: MW5079070
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• 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 Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 71