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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 Problems Unable to Obtain Readings (1516); Power Problem (3010)
Patient Problems Hyperglycemia (1905); Dizziness (2194)
Event Date 11/12/2020
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 review) 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
Customer reported the touch screen of their freestyle libre 2 reader had a delayed response or no response when pressed.Customer experienced dizziness and required treatment of insulin for hyperglycemia by a third-party and a nurse.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
The reported reader (b)(6)) was returned and investigated.Visual inspection was performed on the returned reader and no issues were observed.Touchscreen test was performed and the touchscreen responded properly.No malfunction or product deficiency was identified.Section d3 (email) and section g1 have been updated to reflect current contact information.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported the touch screen of their freestyle libre 2 reader had a delayed response or no response when pressed.Customer experienced dizziness and required treatment of insulin for hyperglycemia by a third-party and a nurse.There was no report of death or permanent injury 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 Key10863302
MDR Text Key217072687
Report Number2954323-2020-11181
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 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2020
Date Manufacturer Received03/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
Patient Weight79
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