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

Model Number 71992-01

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Convulsion/Seizure (4406)

Event Date 04/11/2024

Event Type  Injury  

Event Description

A customer reported that the adc device "no longer worked," and therefore was unable to obtain readings.The customer experienced hypoglycemia with seizures and was provided glucagen for treatment by a third-party.It was indicated that firefighters brought the customer to the hospital and a healthcare professional provided rapid insulin (dose unspecified) for treatment.It was indicated that the customer was hospitalized for an unspecified amount of time.Abbott diabetes care customer service successfully contacted the customer to gain additional details regarding this event and it was indicated that the customer "cannot even confirm if the medical event was related to the adc product." the customer experienced "hypoglycemia or an epilepsia," but the adc device was "not on the arm at that moment." there was no report of death or permanent impairment associated with this event.

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 manufacturing 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.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 19210299
• MDR Text Key: 341352205
• Report Number: 2954323-2024-14736
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/16/2024
• 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