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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); No Code Available (3191)

Event Date 02/12/2020

Event Type  Injury  

Event Description

Hospitalized for septic shoulder joint while using continuous glucose monitor freestyle libre worn on the same arm near shoulder.Patient had been using the device since (b)(6) 2019 and this occurred in (b)(6) 2020.The septic shoulder joint required surgical debridement and 21 days of iv antibiotics.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE CONTINUOUS MONITOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT LABORATORIES / ABBOTT DIABETES CARE, INC.
• MDR Report Key: 10004674
• MDR Text Key: 189444162
• Report Number: MW5094276
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• 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): Hospitalization; Life Threatening
• Patient Age: 34 YR
• Patient Weight: 83