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

Model Number 71562-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Unspecified Infection (1930)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

The sensor and adhesive patch were returned, and a visual inspection was completed, no issues were identified.The product was forwarded to extended investigation.The investigation conducted indicates that both the applicator and sharp passed all tests and met all specifications prior to release.Dose audit reports were reviewed and demonstrated the continued effectiveness of the established sterilization process for libre sensor products.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, which demonstrated that all monitoring processes continue to meet adc requirements.Thus, this complaint is not confirmed.The date of event 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

An hcp reported a customer had an adverse skin reaction while wearing the adc freestyle libre pro sensor and experienced a rash and soreness at the sensor site.Hcp contact was made and the customer was prescribed the antibiotic "t- bact (mupirocin) and the steroid, betnovate (betamethasone) ointment, as treatment.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE PRO
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: tara williamson ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644472
• MDR Report Key: 9339222
• MDR Text Key: 166899965
• Report Number: 2954323-2019-09042
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P150021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71562-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2019
• 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: 55 YR