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

Model Number 71953-01

Device Problem Data Problem (3196)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Diaphoresis (2452); Shaking/Tremors (2515)

Event Date 07/08/2021

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 it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre reader were 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 freestyle libre 2 reader failed to store data regarding how much insulin customer had treated with.The caller reported that as a result of this the customer experienced hypoglycemia, with shaking, sweating, and loss of consciousness.The customer required treatment of glucagon injection from healthcare professional.The caller reported customer also received insulin (type unknown).There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the reader and no issues were observed.Insulin log was downloaded.Rapid acting insulin was observed with units in log book and in parsed insulin log.High control solution test was performed.Rapid acting insulin saved in log book with units displayed.Long acting insulin is saved in log book.Therefore this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller reported that the freestyle libre 2 reader failed to store data regarding how much insulin customer had treated with.The caller reported that as a result of this the customer experienced hypoglycemia, with shaking, sweating, and loss of consciousness.The customer required treatment of glucagon injection from healthcare professional.The caller reported customer also received insulin (type unknown).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: 12198207
• MDR Text Key: 262509643
• Report Number: 2954323-2021-76740
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 09/20/2022

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: 07/08/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 08/28/2022
• Supplement Dates FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2020
• 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 Sex: Female
• Patient Weight: 87 KG