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

Model Number 71953-01

Device Problem Failure to Charge (1085)

Patient Problems Headache (1880); Hypoglycemia (1912); Blurred Vision (2137); Loss of consciousness (2418); Diaphoresis (2452)

Event Date 11/07/2022

Event Type  Injury  

Event Description

A customer reported that the adc device would no longer charge.The caller reported that due to this issue, the customer developed symptoms of blurred vision, sweating, headache, and lost consciousness.Emergency services were called, and a capillary result of 52 mg/dl was obtained, and customer provided unspecified treatment to raise glucose.The customer was transferred to hospital where a capillary result of 110 mg/dl was obtained, and no further treatment was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

At this time, product has not yet been returned and the provided serial number is not valid.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.A tripped trend review was conducted for the reported complaint and freestyle libre reader, and no trends were identified that would indicate any product related issues.The device mfg date is unknown.The date entered 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.

• 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: 15888538
• MDR Text Key: 304556349
• Report Number: 2954323-2022-43822
• 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: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• 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: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2022
• 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