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); Erythema (1840); Unspecified Infection (1930); Pain (1994)

Event Date 08/01/2018

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

Abbott diabetes care (adc) received a medwatch report which reported the following information: customer who is also a healthcare professional reported experiencing an allergic reaction while wearing an adc freestyle libre sensor.On (b)(6) 2018, customer experienced symptoms described as "erythema of skin, firm 2-3 mm nodule at the insertion point, abscess like features at skin surface, warm surrounding skin, 2 to 3 cms firm nodule in skin, painful to light touch, pain so significant that at night he elevated arm on another pillow so that the area should not touch the bed".Customer self treated with fluocinonide (topical steroid) cream and neosporin (antibiotic) for 10 days but the skin nodule still persisted.Customer further reported that the skin was thoroughly cleaned with alcohol pads before applying the sensor.There was no report of death or permanent injury associated with this event.

Event Description

Abbott diabetes care (adc) received a medwatch report which reported the following information: customer who is also a healthcare professional reported experiencing an allergic reaction while wearing an adc freestyle libre sensor.On 01-aug-2018, customer experienced symptoms described as "erythema of skin, firm 2-3 mm nodule at the insertion point, abscess like features at skin surface, warm surrounding skin, 2 to 3 cms firm nodule in skin, painful to light touch, pain so significant that at night he elevated arm on another pillow so that the area should not touch the bed".Customer self treated with fluocinonide (topical steroid) cream and neosporin (antibiotic) for 10 days but the skin nodule still persisted.Customer further reported that the skin was thoroughly cleaned with alcohol pads before applying the sensor.There was no report of death or permanent injury associated with this event.

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 and determined that there was no indication that the product did not meet specification dhrs (device history review) for all 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 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.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 libre sensors and there were no confirmed complaints within the trend data in this review.Therefore, there were no adverse trends that indicate any potential product related issues.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: 7911796
• MDR Text Key: 121848907
• Report Number: 2954323-2018-07246
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• 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: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention