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

Model Number 71953-01

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Nausea (1970); Dizziness (2194); Polydipsia (2604)

Event Date 12/30/2023

Event Type  Injury  

Event Description

A caller reported that the customer encountered a scan error with the adc device.Due to this, the customer was unable to obtain readings or receive glucose alarms and experienced dizziness and dehydration.The customer was diagnosed with hyperglycemia and received fluids via iv for treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Reader (b)(6) & sensor (b)(6) were returned and investigated.Visual inspection has been performed on the returned products and no issues were observed.The reader powered on with the button.The reader log was downloaded and the date and time were set successfully.The sensor plug was properly seated and no physical damage was observed to the sensor patched.Visual inspection was performed sensor plug assembly and a cracked sensor neck was observed.However, a cracked sensor neck did not affect the ability for sensor to scan, nor contributed to customer complaint.The sensor was found to be in sensor state 3 (indicating active state).The returned sensor and reader communicated successfully and no issue were observed.No malfunction or product deficiency was identified.Therefore, this issue is not confirmed.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.Dhrs (device history record) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.Dhrs (device history record) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.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 CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 18590138
• MDR Text Key: 333863419
• Report Number: 2954323-2024-03444
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599803001
• UDI-Public: 00357599803001
• 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: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Date Manufacturer Received: 12/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention