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

Model Number 71953-01

Device Problem No Device Output (1435)

Patient Problems Hypoglycemia (1912); Diaphoresis (2452)

Event Date 12/14/2022

Event Type  Injury  

Manufacturer Narrative

The product has been requested for investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported that the adc device would not power on with a button press.Due to this, they were unable to monitor glucose with the device and experienced hypoglycemia symptoms of sweating.The customer was administered "iv tto, sg%" and other unknown treatments and then taken to the emergency for further monitoring.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

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 reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.Reader (b)(6) has been returned and investigated.Visual inspection was performed in the returned reader and no issues were observed.The reader did not turn on with button, strip, or usb cable insertion.The meter did not communicate with the computer.Extended investigation has also been performed.Visual inspection was performed on the returned reader printed circuit board assembly (pcba ) and no damage or contamination was observed.Observed the crystal(y1) signal was not oscillating.The crystal was re-flowed on the returned reader and attempted to power on the reader.The returned reader was able to power on successfully with button press.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported that the adc device would not power on with a button press.Due to this, they were unable to monitor glucose with the device and experienced hypoglycemia symptoms of sweating.The customer was administered "iv tto, sg%" and other unknown treatments and then taken to the emergency for further monitoring.No further information was provided.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported that the adc device would not power on with a button press.Due to this, they were unable to monitor glucose with the device and experienced hypoglycemia symptoms of sweating.The customer was administered "iv tto, sg%" and other unknown treatments and then taken to the emergency for further monitoring.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

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 reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.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: 16186933
• MDR Text Key: 307513794
• Report Number: 2954323-2023-02744
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 05/12/2023

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 Model Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 01/31/2023; 04/24/2023
• Supplement Dates FDA Received: 02/17/2023; 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2020
• 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