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

Model Number 71702-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Itching Sensation (1943); Skin Irritation (2076); Swelling (2091); Infection, Pyrogenic (2246)

Event Date 12/01/2017

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 date of event is unknown.The date entered is the awareness date.The date of mfg is unknown.The date entered is the awareness date.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported experiencing an infection related to a freestyle libre sensor.The customer indicated that after 3-4 days an ¿itchy reaction¿ occurred.The customer further reported experiencing the following symptoms: infection, redness, itching, suppuration, and swelling.The customer had contact with an hcp who prescribed fucidine cream 2% (an antibiotic) to apply twice a day.

Manufacturer Narrative

This serves as a correction report.(common device name) was incorrectly documented in the initial mdr 30 day report.Common device name has been updated.

Event Description

A customer reported experiencing an infection related to a freestyle libre sensor.The customer indicated that after 3-4 days an ¿itchy reaction¿ occurred.The customer further reported experiencing the following symptoms: infection, redness, itching, suppuration, and swelling.The customer had contact with an hcp who prescribed fucidine cream 2% (an antibiotic) to apply twice a day.

Manufacturer Narrative

No product has been returned.Extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The provided serial (b)(4) was determined to be invalid.Dhrs (device history review) for all libre sensors and libre sensor kits within expiration at the time of complaint were reviewed and the dhr review showed there were no deviations from the validated manufacturing process and no issues identified that could have led to the complaint.Dose audit reports were reviewed and demonstrated the continued effectiveness of the established sterilization process for libre sensor kits.Environmental monitoring reports were also 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 and showed no trips for the complaint and libre sensors.If the product is returned, the case will be re-opened and a physical investigation will be performed.

Event Description

A customer reported experiencing an infection related to a freestyle libre sensor.The customer indicated that after 3-4 days an ¿itchy reaction¿ occurred.The customer further reported experiencing the following symptoms: infection, redness, itching, suppuration, and swelling.The customer had contact with an hcp who prescribed fucidine cream 2% (an antibiotic) to apply twice a day.

• 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
• Manufacturer (Section G): ABBOTT DIABETES CARE INC.; 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 Key: 7153298
• MDR Text Key: 96001377
• Report Number: 2954323-2017-09172
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71702-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 100