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 Problem Bacterial Infection (1735)

Event Date 11/17/2017

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 device manufacturer date for the reported sensor is unknown.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Abbott diabetes care received a user report from the (b)(6), which reported the following information: a hospital reported a customer experienced an infection while wearing an adc freestyle libre sensor.It was further reported that on an unspecified date/time the customer was diagnosed with both necrotizing fasciitis, caused by strep b, at the sensor insertion site, and (b)(6).The customer was also diagnosed with fasciitis of the inner aspect of the customer¿s right thigh; which was thought to have entry via an orthopedic shoe.The customer was treated with unspecified antibiotics.Attempts to gather additional have thus far been unsuccessful.

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 there was no indication that the product did not meet specification.Dhrs (device history review) for all fs libre sensors and 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 and no issues identified that could have led to the complaint.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

Abbott diabetes care received a user report from the french competent authority, ansm, which reported the following information: a hospital reported a customer experienced an infection while wearing an adc freestyle libre sensor.It was further reported that on an unspecified date/time the customer was diagnosed with both necrotizing fasciitis, caused by strep b, at the sensor insertion site, and (b)(6).The customer was also diagnosed with fasciitis of the inner aspect of the customer¿s right thigh; which was thought to have entry via an orthopedic shoe.The customer was treated with unspecified antibiotics.Attempts to gather additional have thus far been unsuccessful.

• 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: 7118634
• MDR Text Key: 94929674
• Report Number: 2954323-2017-08809
• 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: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• 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: 03/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2017
• 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