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

Model Number 71992-01

Device Problem Device Alarm System (1012)

Patient Problems Hyperglycemia (1905); Pain (1994); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 04/19/2021

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 kit were reviewed and the dhrs showed the libre sensor and libre sensor kit 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

An alarm issue was reported with the freestyle libre 2 sensor.Customer reported the high glucose alarm did not sound and because of this, he experienced symptoms described as blurred sight, loss of strength, body pain and cramping.Customer was unable to self-treat and required treatment of rapid insulin by a third-party.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.A visual inspection was performed on the returned sensor patch and no issues were observed.Extracted data from the returned sensor using approved software.Sensor found to be in state 5 (indicating normal termination).The sensor plug was properly seated, and no failure modes observed on the sensor plug assembly during visual inspection.The sensor was activated with a known good reader to perform linearity test and the linearity test successfully activated high glucose alarms.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the freestyle libre 2 sensor.Customer reported the high glucose alarm did not sound and because of this, he experienced symptoms described as blurred sight, loss of strength, body pain and cramping.Customer was unable to self-treat and required treatment of rapid insulin by a third-party.There was no report of death or permanent injury 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
• MDR Report Key: 11735827
• MDR Text Key: 247661040
• Report Number: 2954323-2021-67595
• 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: 09/23/2021

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 Expiration Date: 02/28/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 70