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

Model Number 71992-01

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

Patient Problems Hypoglycemia (1912); Nausea (1970)

Event Date 02/13/2024

Event Type  Injury  

Event Description

A customer reported a "replace sensor" error message with the adc device and was therefore unable to obtain readings.As a result, the customer experienced "panicking" and nausea.It was indicated that the customer was provided sugar for treatment by a non-healthcare professional.No further treatment was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor 3mh00uyt1jh has been returned and investigated.Performed a visual inspection on the returned sensor pack; no issues were observed.The sensor plug was not properly seated.Performed a visual inspection on the plug assembly, observed crack sensor neck and sensor side snapes curled which is consistent with an unseated plug.The damage to the sensor plug is consistent with incorrect assembly.Therefore, this issue is not confirmed to use due to plug not properly seated.An extended investigation has been performed for the reported complaint.The dhr for the libre sensor and sensor kit indicated by the serial number provided by the customer was reviewed.The dhrs showed the libre sensor and sensor kits passed all tests prior to release and there was no indication that the product did not meet specifications.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: 18904249
• MDR Text Key: 337667008
• Report Number: 2954323-2024-08765
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2023
• 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