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

Model Number 72081-01

Device Problems Unable to Obtain Readings (1516); Firing Problem (4011)

Patient Problem Hypoglycemia (1912)

Event Date 08/14/2022

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

An insertion issue was reported with the adc device.Customer reported the inserter did not fire and therefore the sensor could not be applied.As a result, the customer experienced hypoglycemia and was unable to self-treat.The customer presented to the hospital and was provided sugar for treatment by a health care provider for a diagnosis of low blood sugar.Readings were performed by the healthcare professional using an hcp meter however, the results were unknown to the customer.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history review) for libre sensor kits were reviewed and the dhrs showed the libre sensor kits passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An insertion issue was reported with the adc device.Customer reported the inserter did not fire and therefore the sensor could not be applied.As a result, the customer experienced hypoglycemia and was unable to self-treat.The customer presented to the hospital and was provided sugar for treatment by a health care provider for a diagnosis of low blood sugar.Readings were performed by the healthcare professional using an hcp meter however, the results were unknown to the customer.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Performed a visual investigation on the returned sensor; no issue was observed.The applicator and cap were returned; and no issues were observed upon visual investigation.No malfunction or product deficiency was identified.Therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An insertion issue was reported with the adc device.Customer reported the inserter did not fire and therefore the sensor could not be applied.As a result, the customer experienced hypoglycemia and was unable to self-treat.The customer presented to the hospital and was provided sugar for treatment by a health care provider for a diagnosis of low blood sugar.Readings were performed by the healthcare professional using an hcp meter however, the results were unknown to the customer.There was no report of death or permanent injury associated with this event.

• 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: 15324250
• MDR Text Key: 298932419
• Report Number: 2954323-2022-31710
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: VERIFY
• 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,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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