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 Itching Sensation (1943); Skin Irritation (2076)

Event Date 12/12/2017

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 exact date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.The device manufacturer date for the reported sensor 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

A customer reported experiencing an allergic reaction after applying a freestyle libre sensor.The customer reported that after 24 hours of applying the sensor they experienced the following symptoms: ¿itching, blister, reddening, for 2 days after them symptoms disappear.¿ the customer further reported treating the area with panthenol (b5) and prednicarbat (corticosteroid) ointment received from a healthcare provider.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

This serves as a correction report.(common device name) was incorrectly documented in the initial mdr 30 day report.Common device name has been updated.

Event Description

A customer reported experiencing an allergic reaction after applying a freestyle libre sensor.The customer reported that after 24 hours of applying the sensor they experienced the following symptoms: ¿itching, blister, reddening, for 2 days after them symptoms disappear.¿ the customer further reported treating the area with panthenol and prednicarbate (corticosteroid) ointment received from a healthcare provider.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Additional information: ( device mfg date) has been updated.Visual inspection performed on the returned sensor patch, no issues observed.Sensor plug was properly seated.Observed that the adhesive patch was not returned with the puck.Extended investigation has also been performed for the reported complaint.Data was extracted using approved software and visual inspection was performed on all returned pucks, and no anomalies were found.A review was performed to check for potential issues relating to sterility or endotoxin levels, focusing on environmental monitoring data from third party manufacturers (tpms), final product bioburden and endotoxin levels, and sterilization dose audits.No adverse trends were identified, and no evidence was found to indicate that product manufactured during this period was subjected to any atypical conditions relating to sterility or endotoxin levels.The extended investigation showed all processes were effective and did not find any abnormalities with the units.The complaint is not confirmed.

Event Description

A customer reported experiencing an allergic reaction after applying a freestyle libre sensor.The customer reported that after 24 hours of applying the sensor they experienced the following symptoms: ¿itching, blister, reddening, for 2 days after the symptoms disappear.¿ the customer further reported treating the area with panthenol and prednicarbat (corticosteroid) ointment received from a healthcare provider.There was no report of death or permanent impairment associated with this event.

• 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
• Manufacturer (Section G): ABBOTT DIABETES CARE INC.; 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: 7133903
• MDR Text Key: 95360127
• Report Number: 2954323-2017-08976
• 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,Followup
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Date Manufacturer Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2017
• 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: 42 YR
• Patient Weight: 60