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 Problems Hypoglycemia (1912); Convulsion/Seizure (4406)

Event Date 12/19/2021

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 there was no indication that the product did not meet specification.Dhrs for the libre reader was 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 adc freestyle libre 2 reader did not give any results after the blood sample was applied.As a result, the customer was unable to obtain glucose results and experienced a seizure.The customer had contact with a healthcare provider who administered glucose via injection as treatment for the diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The reported meter (b)(6) was returned and investigated.Visual inspection was performed and no issues were observed.Control solution testing was performed and all results were satisfactory.No malfunction or product deficiency has been identified.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller reported that the adc freestyle libre 2 reader did not give any results after the blood sample was applied.As a result, the customer was unable to obtain glucose results and experienced a seizure.The customer had contact with a healthcare provider who administered glucose via injection as treatment for the diagnosis of hypoglycemia.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: 13119196
• MDR Text Key: 282975431
• Report Number: 2954323-2021-97409
• 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
• Report Date: 08/01/2022

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?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2020
• 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 Weight: 80 KG