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 Abscess (1690); Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994)

Event Date 10/06/2018

Event Type  Injury  

Manufacturer Narrative

The reported product is not expected to be returned.A follow-up report will be filed if product is returned or 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 after 14 days of wearing an adc freestyle libre sensor.On (b)(6) 2018, customer experienced symptoms described as pain, abscess and purulent discharge at the insertion site and was.Customer was reportedly hospitalized for the drainage of the wound and was treated with tulle silver (chlorhexidine - antiseptic/silver sulphadiazine - antibiotic) dressing, betadine (povidone-iodine) serum and absorbent dressing for 6 weeks.There was no report of death or permanent injury associated with this event.

Event Description

Customer reported experiencing an adverse skin reaction after 14 days of wearing an adc freestyle libre sensor.On (b)(6) 2018, customer experienced symptoms described as pain, abscess and purulent discharge at the insertion site and was.Customer was reportedly hospitalized for the drainage of the wound and was treated with tulle silver(chlorhexidine - antiseptic/silver sulphadiazine - antibiotic) dressing, betadine (povidone-iodine) serum and absorbent dressing for 6 weeks.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Since no product has been returned, extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kit were reviewed and showed the libre sensor and sensor kit passed all tests prior to release.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.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 if 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.

• 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
• MDR Report Key: 8166846
• MDR Text Key: 130463318
• Report Number: 2954323-2018-09614
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• 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: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 58