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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 Battery Problem (2885)
Patient Problems Hypoglycemia (1912); Dizziness (2194); Diaphoresis (2452)
Event Date 11/13/2021
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 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 being unable to test using his adc freestyle libre 2 reader due to the reader being dropped and not turning on with button press.Customer experienced dizziness, sweating, blurred vision and required treatment of coca-cola provided by a third party.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Reader (b)(6) has been returned and investigated.Visually inspected the reader and no issues were observed.Reader's button was not damaged.Reader did not turn on with button, strip, or usb cable insertion.Unable to extract the data from reader due to bnp-1 issue.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported being unable to test using his adc freestyle libre 2 reader due to the reader being dropped and not turning on with button press.Customer experienced dizziness, sweating, blurred vision and required treatment of coca-cola provided by a third party.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
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key12866290
MDR Text Key281192404
Report Number2954323-2021-93428
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeSP
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 07/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
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? Device Returned to Manufacturer
Date Manufacturer Received06/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
Patient Weight68 KG
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