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 Fainting (1847); Hypoglycemia (1912)

Event Date 11/23/2020

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported that the adc freestyle libre 2 reader would not power on upon button press or test strip insertion.The customer experienced unspecified symptoms of hypoglycemia, fainted, and received an unspecified emergency injection.No additional information was provided.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported that the adc freestyle libre 2 reader would not power on upon button press or test strip insertion.The customer experienced unspecified symptoms of hypoglycemia, fainted, and received an unspecified emergency injection.No additional information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history record) for the libre 2 reader were reviewed and the dhrs showed the libre 2 reader passed all tests prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.Sections h-6 (evaluation codes) and h-10 (addtl mfg narrative ) have been updated as the investigation results were omitted from the previous (initial) report.

Manufacturer Narrative

The reported reader was returned and investigated.Visual inspection has been performed on the returned reader and no issues were observed.The reader powered on with button press.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.Additional information section g1: (contact office first name, contact office last name, contact office phone number, and contact office email) have been updated.

Event Description

A customer reported that the adc freestyle libre 2 reader would not power on upon button press or test strip insertion.The customer experienced unspecified symptoms of hypoglycemia, fainted, and received an unspecified emergency injection.No additional information was 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
• MDR Report Key: 10924741
• MDR Text Key: 218902370
• Report Number: 2954323-2020-12265
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• 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
• Date Returned to Manufacturer: 01/08/2021
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention