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

Model Number 71953-01

Device Problems Failure to Power Up (1476); Unable to Obtain Readings (1516)

Patient Problems Fall (1848); Convulsion/Seizure (4406)

Event Date 07/09/2021

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.Dhrs (device history record) for the libre reader were reviewed and the dhrs showed the libre reader 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 caller reported that the customer's freestyle libre 2 reader would not power on upon button press or test strip insertion, and as a result was unable to monitor glucose or be alerted when glucose was low.Customer was on a ladder and experienced seizure, causing him to fall down.No further details were provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated with retained test strips.Visual inspection has been performed and no issues were observed.The reader did not on power with button, test strips, or usb cable insertion.Connected the reader to a computer and the reader was not recognized.The reader was sent for further investigation and de-cased, no issues were observed upon visual inspection.Measured the returned battery and results were outside of specifications.Placed the reader into the printed circuit board assembly (pcba) test fixture and applied pressure to the central processing unit (cpu) and the reader did not turn on.Replaced the returned battery with a new unused battery and placed the reader into the pcba test fixture.Pressure was applied to the cpu and the reader still did not power on.Extended investigation has also been performed.Further visual inspection of the reader was performed and scratches were observed.The returned battery was placed in a new unsed reader and left to charge.The returned battery fully charged in the retained reader.Visual inspection was performed on the reader's pcba (printed circuit board assembly) and no issues were observed.The returned reader was placed into the test fixture and pressure was appied to the microcontroller unit (mcu), the reader successfully powered up with button depression and strip insertion.The reader self test was performed and passed.Therefore, this issue has been confirmed to intermittent issue of the cpu.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller reported that the customer's freestyle libre 2 reader would not power on upon button press or test strip insertion, and as a result was unable to monitor glucose or be alerted when glucose was low.Customer was on a ladder and experienced seizure, causing him to fall down.No further details were provided.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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 12288381
• MDR Text Key: 265404885
• Report Number: 2954323-2021-79276
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599803001
• UDI-Public: 00357599803001
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Device Catalogue Number: 71953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male