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 Abscess (1690); Erythema (1840); Unspecified Infection (1930); Pain (1994); Skin Inflammation (2443)

Event Date 08/22/2019

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 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 while wearing an adc freestyle libre sensor, reporting symptoms described as "purulent ball, severe pain, redness, inflammation of elbow to shoulder, and fever for 2 days".On (b)(6) 2019, customer had contact with a healthcare provider who confirmed an infection and prescribed pyostacine 500mg oral antibiotic for treatment.On (b)(6) 2019, customer had additional contact with the healthcare provider who confirmed the presence of an abscess and performed an incision and drainage and advised the customer to continue his antibiotic treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(4) has been returned and investigated.Visual inspection has been performed on the returned sensor patch and no issues were observed.The adhesive patch was not returned with the puck.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The investigation determined that there were no issues related to the puck and the plug assembly.No adhesive was returned.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.Dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and 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 products.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 processes were identified as effective thus this complaint is not confirmed.Section updated based on product download.

Event Description

Customer reported experiencing an adverse skin reaction while wearing an adc freestyle libre sensor, reporting symptoms described as "purulent ball, severe pain, redness, inflammation of elbow to shoulder, and fever for 2 days".On (b)(6)2019, customer had contact with a healthcare provider who confirmed an infection and prescribed pyostacine 500mg oral antibiotic for treatment.On (b)(6)2019, customer had additional contact with the healthcare provider who confirmed the presence of an abscess and performed an incision and drainage and advised the customer to continue his antibiotic 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
• Manufacturer Contact: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 9084748
• MDR Text Key: 159077848
• Report Number: 2954323-2019-07248
• 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: 02/04/2020

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: 07/26/2019
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2019
• 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: 59 YR
• Patient Weight: 79