MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 72081-01

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

Patient Problems Hypoglycemia (1912); Dizziness (2194); Coma (2417)

Event Date 06/12/2023

Event Type  Injury  

Event Description

An email complaint was received in which it was reported a customer received a "no active sensor" message on the adc device and was unable to obtain readings.Customer further reported in the email message: ¿unfortunately, after the sensor expired, i fell so low that the emergency doctor "woke me up" in a coma.I then (supposedly) started the new sensor, but after an estimated 20 minutes it had lost signal and then it said no active sensor is there.I then thought that maybe i hadn't activated the new sensor because i was still "dizzy" and did it again, which worked.However, the signal was lost again and then the display showed that there was no active sensor.I then tried several more times to activate this sensor, but after a few hours i set a new sensor.¿ no third-party treatment was reported.No further details were provided and attempts to gather additional information were unsuccessful.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and sensor kit were reviewed, and the dhrs showed the 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.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Performed a visual inspection on returned sensor patch, no issues were observed.The sensor log data was downloaded using approved software.Sensor found to be in state 1 (indicating storage state) with an event log 5 indicating insertion failure.There was no watermark at the base of the tail (indicating that the sensor was never inserted).Therefore, this issue is not confirmed to tail not properly inserted.Therefore, this issue is not confirmed.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An email complaint was received in which it was reported a customer received a "no active sensor" message on the adc device and was unable to obtain readings.Customer further reported in the email message: ¿unfortunately, after the sensor expired, i fell so low that the emergency doctor "woke me up" in a coma.I then (supposedly) started the new sensor, but after an estimated 20 minutes it had lost signal and then it said no active sensor is there.I then thought that maybe i hadn't activated the new sensor because i was still "dizzy" and did it again, which worked.However, the signal was lost again and then the display showed that there was no active sensor.I then tried several more times to activate this sensor, but after a few hours i set a new sensor.¿ no third-party treatment was reported.No further details were provided and attempts to gather additional information were unsuccessful.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Performed a visual inspection on returned sensor patch, no issues were observed.The sensor log data was downloaded using approved software.Sensor found to be in state 1 (indicating storage state) with an event log 5 indicating insertion failure.Log file showed that the user had attempted to activate the sensor but was not able to get to an active paired state.As a result, sensor returned to storage state (sensor state 1).Also, clinical and historical data were not present indicating that no readings were logged since sensor was not activated.There was no watermark at the base of the tail (indicating that the sensor was never inserted).Therefore, this issue is not confirmed to tail not properly inserted.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An email complaint was received in which it was reported a customer received a "no active sensor" message on the adc device and was unable to obtain readings.Customer further reported in the email message: ¿unfortunately, after the sensor expired, i fell so low that the emergency doctor "woke me up" in a coma.I then (supposedly) started the new sensor, but after an estimated 20 minutes it had lost signal and then it said no active sensor is there.I then thought that maybe i hadn't activated the new sensor because i was still "dizzy" and did it again, which worked.However, the signal was lost again and then the display showed that there was no active sensor.I then tried several more times to activate this sensor, but after a few hours i set a new sensor.¿ no third-party treatment was reported.No further details were provided and attempts to gather additional information were unsuccessful.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 17302722
• MDR Text Key: 318871498
• Report Number: 2954323-2023-29803
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K223435
• 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,Followup
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2023
• 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