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); Blurred Vision (2137); Tingling (2171); Sweating (2444)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned.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.The dhrs (device history review) 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.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.

Event Description

A customer reported receiving a "scan again in 10 minutes" from the adc freestyle libre 2 sensor after 1 day of wear.As a result, the customer was unable to monitor her glucose levels and experienced symptoms of "sweats, blurred vision, tingling in the hands, stuttering when speaking," and was unable to self-treat.Her husband provided her with 2 packets of sugar as treatment.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported receiving a "scan again in 10 minutes" from the adc freestyle libre 2 sensor after 1 day of wear.As a result, the customer was unable to monitor her glucose levels and experienced symptoms of "sweats, blurred vision, tingling in the hands, stuttering when speaking," and was unable to self-treat.Her husband provided her with 2 packets of sugar as treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor 3mh00222um8 has been returned and investigated.The sensor plug is properly seated and no physical damage was observed on the sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.Sim vivo testing (simulation of the electrical signal produced by the sensor tail) was performed and all results were within specification.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.Section d-3 (email) and section g1 (contact office first name, contact office last name, contact office phone number and contact office email) have been updated to (b)(6).

• 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
• MDR Report Key: 10887465
• MDR Text Key: 217924961
• Report Number: 2954323-2020-11684
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 97