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

Model Number 71953-01

Device Problems No Device Output (1435); Unable to Obtain Readings (1516)

Patient Problem Loss of consciousness (2418)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

Reader mcga238-j2704 was returned and investigated.Visual inspection has been performed on the returned reader and no issues were observed.The reader did not turn on with button, strip, or usb cable insertion.The returned reader was connected to the computer and the reader was not recognized.The reader was sent for further investigation and de-cased.Inspection determined that the central processing unit (cpu) was causing the libre reader to be unresponsive to a button press, strip insertion, touchscreen activation, and/or activation of a new sensor.When the cpu was physically pressed against the reader¿s print circuit board (pcb), the reader powered up and passed all internal built-in self-tests, and the complaint behavior was not observed.When the pressure was removed from the cpu, the reader would revert to their reported complaint behavior.Because the reader worked as expected when pressure was applied to the cpu, it was determined that there was poor connection between cpu and pcb.Issue is confirmed.(b)(4).An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.Dhrs (device history review) for the freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor kit passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A battery/no power issue was reported with the freestyle libre 2 reader.Customer reported being unable to test due to the reader not powering on with button press or test strip insertion and experiencing dizziness and a loss of consciousness.There was no report of self-treatment or third-party 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: 11948440
• MDR Text Key: 254568517
• Report Number: 2954323-2021-71471
• 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
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• 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 Returned to Manufacturer: 05/27/2021
• Date Manufacturer Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 129