MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 72081-01

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Fever (1858); Diaphoresis (2452); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and freestyle libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered in section h4 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 complaint was received via social media.An adhesive issue was reported with the adc sensor.The sensor prematurely detached and the customer was unable to obtain readings.As a result, customer experienced symptoms described as "fever, profuse sweating and post-sepsis condition".The customer reported unspecified treatment from third-party due to this issue.Customer refused to troubleshoot further.There was no report of death or permanent impairment associated with this event.

Event Description

A complaint was received via social media.An adhesive issue was reported with the adc sensor.The sensor prematurely detached and the customer was unable to obtain readings.As a result, customer experienced symptoms described as "fever, profuse sweating and post-sepsis condition".The customer reported unspecified treatment from third-party due to this issue.Customer refused to troubleshoot further.There was no report of death or permanent impairment associated with this event.Update: during the initial registration of the case, the customer did not indicate whether a healthcare facility was involved.Adc customer services performed additional follow up with the customer in response to receipt of this email and were informed by the customer that medical treatment was not required and no third-party intervention was required nor loss of consciousness/seizure had occurred.No further injury was reported.

Manufacturer Narrative

The product has been requested back for an investigation.At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and freestyle libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.The following section(s) have been updated: section b2: updated outcomes attributed to ae section b5: updated describe event or problem section g3: date received by mfg section h2: if follow-up, what type? section h6: adverse event problem.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 18183941
• MDR Text Key: 328693067
• Report Number: 2954323-2023-50858
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K223435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention