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U.S. Department of Health and Human Services

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

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ABBOTT LABORATORIES / ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE CONTINUOUS MONITOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
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).
 
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Brand NameFREESTYLE LIBRE CONTINUOUS MONITOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT LABORATORIES / ABBOTT DIABETES CARE, INC.
MDR Report Key10004674
MDR Text Key189444162
Report NumberMW5094276
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 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
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: 04/27/2020 Patient Sequence Number: 1
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