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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 Problems Low Readings (2460); Appropriate Term/Code Not Available (3191)
Patient Problem Skin Irritation (2076)
Event Date 04/24/2019
Event Type  Injury  
Manufacturer Narrative
This is an initial final report. This issue does not meet reportability criteria, however it is being reported to fda as the complaint was received via medwatch report. If product is returned, this case will be re-opened, an investigation will be conducted,  and a follow-up report will be submitted after all investigation activities are complete. The device mfg date is unknown. The date entered is the date abbott diabetes care became aware of the event. All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Abbott diabetes care received notice of an fda medwatch report submitted by a physician which reported the following: a clinical study participant developed severe local contact dermatitis, with symptoms described as "pruritic rash", while wearing the adc freestyle libre pro sensor. Additionally, it was reported that the patient had multiple blinded recordings of hypoglycemia, which were later reported to be asymptomatic. It was further reported that the customer removed the sensor prematurely and self-treated with neosporin ointment. There was no report of third-party treatment or intervention. Based on the information received, there was no report of serious 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 Key9071113
MDR Text Key158735723
Report Number2954323-2019-07134
Device Sequence Number1
Product Code MDS
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,other
Reporter Occupation
Type of Report Initial
Report Date 09/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2019
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 Received08/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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