MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71953-01

Device Problem Date/Time-Related Software Problem (2582)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Diaphoresis (2452)

Event Date 12/08/2023

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned.An 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 record) for the freestyle libre reader was reviewed and the dhrs showed the freestyle libre reader passed all tests prior to release.The date the incident occurred is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.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

A date/time settings issue was reported with the adc device.The customer reported experiencing symptoms described as "sweaty, couldn't focus, unable to reach anything nearby because they couldn't reach anything," and a loss of consciousness.The customer regained consciousness and was able self-treat with a chocolate bar.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 18361052
• MDR Text Key: 330930617
• Report Number: 2954323-2023-54515
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K193371
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other