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 Hyperglycemia (1905); Loss of consciousness (2418)

Event Date 07/30/2021

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.The date of event 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

Customer reported his adc freestyle libre 2 reader displayed incorrect unit of measurement and he therefore experienced a medical event.Customer experienced loss of consciousness and was treated with insulin injection (dose unknown) by his wife.No further treatment was reported.There was no report of death or permanent impairment associated with this event.

Event Description

Customer reported his adc freestyle libre 2 reader displayed incorrect unit of measurement and he therefore experienced a medical event.Customer experienced loss of consciousness and was treated with insulin injection (dose unknown) by his wife.No further treatment was reported.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

No product has been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specifications.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, 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

Customer reported his adc freestyle libre 2 reader displayed incorrect unit of measurement and he therefore experienced a medical event.Customer experienced loss of consciousness and was treated with insulin injection (dose unknown) by his wife.No further treatment was reported.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

An extended investigation has also been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre sensor and libre sensor kit passed all tests prior to release.Reader mbmb061-j2554 has been returned and investigated.Performed visual inspection on the returned reader and no issue were observed.Observed unit of measurement for reader is correct.No malfunction or product deficiency has been identified.Therefore, the issue is not confirmed.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: 12309093
• MDR Text Key: 266070733
• Report Number: 2954323-2021-79805
• 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: 11/19/2021

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
• Date Returned to Manufacturer: 08/20/2021
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 08/11/2021; 11/02/2021
• Supplement Dates FDA Received: 08/23/2021; 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2021
• 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 Sex: Male