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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE INC FREESTYLE LIBRE PRO SENSOR FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71562-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545)
Event Date 06/30/2021
Event Type  Injury  
Manufacturer Narrative
At this time, product has not yet been returned. An extended investigation has been performed for the reported complaint. There was no indication that the product did not meet specification. The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor. Dhrs (device history record) for the freestyle libre sensor kit were reviewed, and the dhrs showed the and freestyle libre sensor kit passed all tests prior to release. Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor products. Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality. If the product is returned, a physical investigation will be performed and a follow-up report submitted. All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A healthcare professional reported that a patient experienced a skin reaction at the site of the freestyle libre pro sensor. The customer was experiencing pain with wear, and 4 days after sensor removal, the patient developed a rash at site of wear. It was indicated that the customer required treatment; however, no further information was provided. Attempts to contact the healthcare professional for further clarification and information have thus-far been unsuccessful. There was no report of death or permanent injury associated with this event.
 
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Brand NameFREESTYLE LIBRE PRO SENSOR
Type of DeviceFLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key12247037
MDR Text Key264115358
Report Number2954323-2021-78025
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2021
Device Model Number71562-01
Device Catalogue Number71562
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 Received07/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2021
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: 07/29/2021 Patient Sequence Number: 1
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