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 Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Skin Irritation (2076); Swelling (2091)

Event Date 02/18/2019

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 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.Common device name - corrected from the initial 30-day report.

Event Description

An hcp reported a customer experienced an allergic skin reaction on day 3 of wear of the adc freestyle libre pro sensor.The customer presented with "redness and bumps" just on her right arm and self-treated with benadryl, claritin and hydrocortisone cream.A couple of days later, the redness and bumps from the right upper arm had spread and "weeping yellowish" discharge was noted.The customer had hcp contact and was administered an injection of the steroid, kenalog (dose unknown,) and was given a prescription for augmentin (amoxicillin, dose unknown) for treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

This serves as a correction report.Emdr-62656 (2954323-2019-03773) was submitted in error as in initial and should have been created as a supplemental for a correction related to mdr # emdr-57314 (2954323-2019-02333).

Event Description

An hcp reported a customer experienced an allergic skin reaction on day 3 of wear of the adc freestyle libre pro sensor.The customer presented with "redness and bumps" just on her right arm and self-treated with benadryl, claritin and hydrocortisone cream.A couple of days later, the redness and bumps from the right upper arm had spread and "weeping yellowish" discharge was noted.The customer had hcp contact and was administered an injection of the steroid, kenalog (dose unknown,) and was given a prescription for augmentin (amoxicillin, dose unknown) for 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
• MDR Report Key: 8596675
• MDR Text Key: 144599450
• Report Number: 2954323-2019-03773
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00357599715625
• UDI-Public: 00357599715625
• 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,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• 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?: No
• Date Manufacturer Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 120