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)

Event Date 08/01/2017

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 exact date of event is unknown.The date entered is an approximation based on the information provided by the customer.The device manufacturer date for the reported sensor 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

A customer reported experiencing skin irritation related to the use of a freestyle libre sensor.The customer reported that after 5 days they experienced itching, red skin, blistering.The customer reported having contact with a health care provider in (b)(4) 2017 (date was not specified) and being prescribed a cortisone ointment and being diagnosed with allergic skin reaction.The customer indicated that after removing the sensor and applying the cortisone ointment the area was "ok." no additional treatment was reported.There was no report of death or permanent impairment as a result of the event.

Manufacturer Narrative

No product has been returned.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.A dhr (device history review) for the freestyle libre sensor kit was reviewed and the dhr showed the 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 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.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show that the product has met specifications prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.

Event Description

A customer reported experiencing skin irritation related to the use of a freestyle libre sensor.The customer reported that after 5 days they experienced itching, red skin, blistering.The customer reported having contact with a health care provider in (b)(6) 2017 (date was not specified) and being prescribed a cortisone ointment and being diagnosed with allergic skin reaction.The customer indicated that after removing the sensor and applying the cortisone ointment the area was "ok." no additional treatment was reported.There was no report of death or permanent impairment as a result of the event.

• 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 Contact: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 7133830
• MDR Text Key: 95360012
• Report Number: 2954323-2017-08973
• 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
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• 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: 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2017
• 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: 48 YR
• Patient Weight: 62