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); Loss of consciousness (2418); Convulsion/Seizure (4406); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 12/30/2022

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and 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 error message was reported with the adc device.User exchanged sensors after approximately 4 days in use.Customer received an unspecified error message and was unable to obtain readings.As a result, customer experienced "leg cramps, immobility, and constriction" and loss of consciousness/seizure.User was unable to self-treat, requiring third-party administration of glucose spray for treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection has been performed and no issues were observed.Visual inspection was performed on the sensor plug assembly and no failure modes were observed.The sensor plug was properly seated.No further investigation can be performed at this time as the sensor applicator and sensor pack have not been returned.If sensor applicator and sensor pack is returned, an investigation will be performed.Issue will be closed to no product returned.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An error message was reported with the adc device.User exchanged sensors after approximately 4 days in use.Customer received an unspecified error message and was unable to obtain readings.As a result, customer experienced "leg cramps, immobility, and constriction" and loss of consciousness/seizure.User was unable to self-treat, requiring third-party administration of glucose spray for treatment.There was no report of death or permanent impairment 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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 16146641
• MDR Text Key: 307176417
• Report Number: 2954323-2023-02032
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2022
• 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