MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71940-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Itching Sensation (1943); Skin Irritation (2076); Burning Sensation (2146)

Event Date 12/17/2019

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

Event Description

A customer reported experiencing an adverse skin reaction while wearing the adc freestyle libre sensor.Customer reported experiencing symptoms of redness, itchiness, and a burning sensation at the sensor site.Customer had contact with an hcp who prescribed them betacorten cream for treatment.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported experiencing an adverse skin reaction while wearing the adc freestyle libre sensor.Customer reported experiencing symptoms of redness, itchiness, and a burning sensation at the sensor site.Customer had contact with an hcp who prescribed them betacorten cream for treatment.There was no report of death or permanent injury associated with this event.

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 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 minimum requirements for product quality.Clinical data was reviewed and confirmed that freestyle libre sensor 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, and there were no adverse trends that indicate any potential product related issues.If the product is returned, the case will be re-opened and a physical investigation will be performed.This serves as a correction report.Section d1 (brand name), d4 (model no) were incorrectly documented in initial.Correction has been made.

Manufacturer Narrative

Section d4 serial no.Has been updated from unk to (b)(6).Sensor (b)(6) has been returned and investigated.Visual inspection has been performed and no issues were observed.The adhesive has also been returned and no abnormalities have been observed.No malfunction or product deficiency was identified.

Event Description

A customer reported experiencing an adverse skin reaction while wearing the adc freestyle libre sensor.Customer reported experiencing symptoms of redness, itchiness, and a burning sensation at the sensor site.Customer had contact with an hcp who prescribed them betacorten cream for treatment.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 9582408
• MDR Text Key: 174748405
• Report Number: 2954323-2020-00392
• 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: 08/19/2020

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 Number: 71940-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 03/02/2020; 08/18/2020
• Supplement Dates FDA Received: 03/03/2020; 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR