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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71953-01
Device Problem Power Problem (3010)
Patient Problem Diabetic Ketoacidosis (2364)
Event Date 06/28/2021
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.The device mfg 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 port issue was reported with the freestyle libre 2 reader.Customer reported the reader powered on with button but not test strip insertion.Customer did not experience symptoms but self-presented to a hospital where he/she was admitted for a day and provided unspecified treatment for a diagnosis of diabetic ketoacidosis.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
No product has been returned 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 libre reader, no trends were identified 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 port issue was reported with the freestyle libre 2 reader.Customer reported the reader powered on with button but not test strip insertion.Customer did not experience symptoms but self-presented to a hospital where he/she was admitted for a day and provided unspecified treatment for a diagnosis of diabetic ketoacidosis.There was no report of death or permanent impairment associated with this event.
 
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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
MDR Report Key12174346
MDR Text Key261730537
Report Number2954323-2021-76096
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 08/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71953-01
Was Device Available for Evaluation? No
Date Manufacturer Received08/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight80
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