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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 Display or Visual Feedback Problem (1184)
Patient Problem Hypoglycemia (1912)
Event Date 10/25/2022
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.The date the incident occurred is unknown.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
The customer initially reported being unable to obtain readings due to a touch screen issue with the adc device.A replacement product was ordered and due to a delivery delay, the customer was unable to monitor glucose levels.Customer required unspecified healthcare professional treatment for the diagnosis of hypoglycemia.No further information was provided.There was no report of death or permanent injury associated with this event.
 
Event Description
The customer initially reported being unable to obtain readings due to a touch screen issue with the adc device.A replacement product was ordered and due to a delivery delay, the customer was unable to monitor glucose levels.Customer required unspecified healthcare professional treatment for the diagnosis of hypoglycemia.No further information was provided.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
At this time, product has not yet been returned and a valid serial number has not been provided.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.A tripped trend review was conducted for the reported complaint and freestyle libre reader, and no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date the incident occurred is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.The following sections have been corrected from the initial report: h6 - adverse event problem type of investigation, investigation conclusions.H10 - additional mfg narrative.
 
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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
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key15830559
MDR Text Key303991869
Report Number2954323-2022-42475
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2022
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 Received01/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/25/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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