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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM

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ABBOTT DIABETES CARE INC FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71562-01
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Skin Irritation (2076); Swelling (2091)
Event Date 02/18/2019
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation. A follow-up report will be submitted once additional information is obtained. The device mfg date is unknown. The date is the date abbott diabetes care became aware of the event. All pertinent information available to abbott diabetes care has been submitted. Common device name - corrected from the initial 30-day report.
 
Event Description
An hcp reported a customer experienced an allergic skin reaction on day 3 of wear of the adc freestyle libre pro sensor. The customer presented with "redness and bumps" just on her right arm and self-treated with benadryl, claritin and hydrocortisone cream. A couple of days later, the redness and bumps from the right upper arm had spread and "weeping yellowish" discharge was noted. The customer had hcp contact and was administered an injection of the steroid, kenalog (dose unknown,) and was given a prescription for augmentin (amoxicillin, dose unknown) for treatment. There was no report of death or permanent injury associated with this event.
 
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Brand NameFREESTYLE LIBRE PRO
Type of DeviceFLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
devin dirstine
1360 south loop road
alameda, CA 94502-7001
5108644391
MDR Report Key8596675
MDR Text Key144599450
Report Number2954323-2019-03773
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00357599715625
UDI-Public00357599715625
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71562-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/09/2019 Patient Sequence Number: 1
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