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

Model Number 71992-01

Device Problem Low Readings (2460)

Patient Problems Hyperglycemia (1905); Dizziness (2194)

Event Date 03/25/2024

Event Type  Injury  

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on sensor and no issues were observed.The sensor plug was seated in mount properly.Data was successfully extracted from the returned sensor using approved software.The sensor was found to be in sensor state 3 (indicating normal termination).Removed the sensor plug and inspected the plug assembly, no failure mode observed.Current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.Therefore, the issue is not confirmed.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 low readings issue with the abbott diabetes care (adc) device was reported.The customer received low sensor scan result of 'lo' (reading <40 mg/dl) at 10:43am and the customer experienced dizziness but was able to self-treat orange juice.The paramedics were called and upon arriving at 11:00am, a glucose result of 404 mg/dl was obtained, and the customer was reported treated with intravenous glucose.The customer was transported to the hospital electrocardiogram (ecg) and chest x-ray were performed and the customer was administered unspecified intravenous drip for a diagnosis of hyperglycemia.At around 8pm, a post-treatment blood glucose result of 178 mg/dl was obtained, and no additional treatment was reported.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: 19144152
• MDR Text Key: 340605238
• Report Number: 2954323-2024-13506
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599800000
• UDI-Public: (01)00357599800000(17)2024-06-30(10)KTP007658(91)71992-01-0006
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/19/2024

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: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2024
• 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
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic