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); Device Displays Incorrect Message (2591)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 03/26/2024

Event Type  Injury  

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on the returned sensor and no physical damage was observed with the sensor patch.Extracted data from returned sensor using approved software.No malfunction or product deficiency was identified.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An error message was reported with the abbott diabetes care (adc) device.Customer received a "replace sensor" message and was unable to obtain readings.As a result, customer experienced a loss of consciousness and was unable to self-treat, requiring third-party treatment of "glucose paste/gel" orally by a non-healthcare professional.There was no report of death or permanent impairment 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: 19189910
• MDR Text Key: 341116621
• Report Number: 2954323-2024-14373
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 30357599818006
• UDI-Public: (01)30357599818006(17)2024-07-31(10)T60001640(91)72081-01
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213996
• 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
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2024
• 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