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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71702-01
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Itching Sensation (1943); Skin Irritation (2076); Burning Sensation (2146)
Event Date 07/01/2018
Event Type  Injury  
Manufacturer Narrative
The reported product is not expected to be returned.A follow-up report will be filed if product is returned or additional information is obtained.The date of event is unknown.The date entered is based on customer's report of (b)(6) 2018.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
Customer reported experiencing an adverse skin reaction after 2 days of wearing an adc freestyle libre sensor.Customer experienced symptoms described as itching and burning at the insertion site.Customer had contact with a healthcare professional who prescribed flixovate (fluticasone, a corticosteroid) cream for treatment.No further treatment was reported.
 
Manufacturer Narrative
No product has been returned and a valid serial number has not been provided.Extended investigation has been performed for the reported complaint and 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.Dose audit and environmental monitoring reports were reviewed for issues relating to sterility of the product.The sensor component has no impact on product sterility and therefore, sensor components dhrs were not reviewed.Sensor kit dhrs have been reviewed to assess the manufacturing process, which includes the application of the adhesive to the puck.Dhrs (device history review) for all fs libre sensor kits within expiration at the time of complaint were reviewed, and the dhr review showed no there were no deviations from the validated manufacturing process.Dose audit reports were reviewed and demonstrates 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 minimum requirements for product quality.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed for the reported complaint and fs libre sensors, no tripped trends were observed.If the product is returned, the case will be re-opened and a physical investigation will be performed.
 
Event Description
Customer reported experiencing an adverse skin reaction after 2 days of wearing an adc freestyle libre sensor.Customer experienced symptoms described as itching and burning at the insertion site.Customer had contact with a healthcare professional who prescribed flixovate (fluticasone, a corticosteroid) cream for treatment.No further treatment was reported.
 
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Brand Name
FREESTYLE LIBRE
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
MDR Report Key8329420
MDR Text Key135852722
Report Number2954323-2019-01235
Device Sequence Number1
Product Code PZE
Combination Product (y/n)N
PMA/PMN Number
P160030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 11/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71702-01
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/05/2019
Initial Date FDA Received02/11/2019
Supplement Dates Manufacturer Received10/22/2019
Supplement Dates FDA Received11/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight95
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