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

Model Number 71953-01

Device Problem Battery Problem (2885)

Patient Problem Hyperglycemia (1905)

Event Date 05/06/2022

Event Type  Injury  

Manufacturer Narrative

The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The device manufacturing 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 there was a physical defect to the battery of the adc device and therefore could not use the device to monitor glucose.The customer felt hyperglycemic and had contact with a healthcare professional who obtained a blood glucose result of "over 300 mg/dl." the customer received unspecified injection treatment for hyperglycemia.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported that there was a physical defect to the battery of the adc device and therefore could not use the device to monitor glucose.The customer felt hyperglycemic and had contact with a healthcare professional who obtained a blood glucose result of "over 300 mg/dl." the customer received unspecified injection treatment for hyperglycemia.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

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 was not provided.A valid serial number has not been provided at this time.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Tripped trend reports were reviewed for fs libre reader and complaint, the review did not identify any trends that would indicate any product related issues 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.

Event Description

A customer reported that there was a physical defect to the battery of the adc device and therefore could not use the device to monitor glucose.The customer felt hyperglycemic and had contact with a healthcare professional who obtained a blood glucose result of "over 300 mg/dl." the customer received unspecified injection treatment for hyperglycemia.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned and a valid serial number has not been provided.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Tripped trend reports were reviewed for fs libre reader and complaint, the review did not identify any trends that would indicate any product related issues 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.

• 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: 14429609
• MDR Text Key: 291929934
• Report Number: 2954323-2022-15905
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/02/2022

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?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 05/18/2022; 11/08/2022
• Supplement Dates FDA Received: 06/01/2022; 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• 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