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

Model Number 71953-01

Device Problem Failure to Charge (1085)

Patient Problem Hypoglycemia (1912)

Event Date 07/21/2021

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 caller reported the adc freestyle libre 2 reader is no longer charging therefore, was unable to monitor their blood glucose.As a result, the customer became hypoglycemic and was unable to self-treat.The customer had contact with a healthcare professional who obtained a blood glucose result of 48 mg/dl and provided the customer with sugar and cake as treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Section d4 (serial no) has been updated to unk as the previously submitted information was invalid.Section h4 (device mfg date) has been updated to the device manufacturing date to reflect the unknown serial number.Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned as of this report and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specifications.A tripped trend review was conducted for the reported complaint and fs libre readers, no trends were identified that would indicate any product-related issues.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 the adc freestyle libre 2 reader is no longer charging therefore, was unable to monitor their blood glucose.As a result, the customer became hypoglycemic and was unable to self-treat.The customer had contact with a healthcare professional who obtained a blood glucose result of 48 mg/dl and provided the customer with sugar and cake as treatment.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: 12278917
• MDR Text Key: 265123071
• Report Number: 2954323-2021-78657
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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
• Patient Age: 9 YR
• Patient Weight: 29 KG