Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE PRO; FLASH GLUCOSE MONITORING SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Unspecified Infection (1930); Rash (2033)
Event Date 10/31/2019
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 review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor 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, the case will be re-opened and a physical investigation will be performed.The date of event 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
Customer reported experiencing a skin reaction while wearing an adc freestyle libre pro sensor and experienced symptoms described as "rashes and soreness" at the sensor site.Customer had contact with a healthcare professional who prescribed t-bact (mupirocin) and betnovate (betamethasone) ointment for treatment.There was no report of death or permanent injury associated with this event.
 
Event Description
Customer reported experiencing a skin reaction while wearing an adc freestyle libre pro sensor and experienced symptoms described as "rashes and soreness" at the sensor site.Customer had contact with a healthcare professional who prescribed t-bact (mupirocin) and betnovate (betamethasone) ointment for treatment.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
(device manufactured date) has been updated based on returned product download.The reported sensor (b)(4) has been returned and investigated.The sensor adhesive has been returned.Visual inspection was performed on the returned sensor; no issue was observed.The sensor applicator and sharp have not been returned.An extended investigation has also been performed for the reported complaint.The investigation indicated that the applicator and sharp met specification prior to release.The device history record (dhr) was reviewed and verified that the unit passed all tests.Dose audit reports were reviewed and demonstrated the continued effectiveness of the established sterilization process for libre sensor kits.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc requirements.No malfunction or product deficiency was identified.Extended investigation has also been performed.Dhrs (device history record) for the fs libre sensor kit was reviewed and the dhrs showed the fs 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 reported applicator and sharp is returned, the case will be re-opened, and a physical investigation will be performed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FREESTYLE LIBRE PRO
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
MDR Report Key9341945
MDR Text Key167003377
Report Number2954323-2019-09078
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P150021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71562-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2019
Date Manufacturer Received11/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age55 YR
-
-