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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 Failure to Power Up (1476); Failure to Fire (2610); Key or Button Unresponsive/not Working (4063)
Patient Problem Hyperglycemia (1905)
Event Date 07/21/2023
Event Type  Injury  
Event Description
A button/power issue was reported with the adc device.The meter would not power on with a button press, and the customer was unable to obtain readings.As a result, the customer experienced symptoms described as "high-glucose and high keto." it was reported that the paramedics obtained blood glucose readings of 481 and 267 at the laboratory.As a result, the customer was administered "20 units of insulin, 1 sodium gloride (1 lr- intravenously) and 40 meq calcium".There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
The product has been requested back for an investigation.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 freestyle libre reader were reviewed and the dhrs showed the freestyle 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
A button/power issue was reported with the adc device.The meter would not power on with a button press, and the customer was unable to obtain readings.As a result, the customer experienced symptoms described as "high-glucose and high keto." it was reported that the paramedics obtained blood glucose readings of 481 and 267 at the laboratory.As a result, the customer was administered (b)(4).Units of insulin, 1 sodium gloride (1 lr- intravenously) and 40 meq calcium".There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
The product has been requested back for an investigation.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 freestyle libre reader were reviewed and the dhrs showed the freestyle 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.This serves as a correction report.Section(s) updated as follows: b1: updated to adverse event from product problem.
 
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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 Key17437114
MDR Text Key320196354
Report Number2954323-2023-33051
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeBE
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 08/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number71953-01
Was Device Available for Evaluation? No
Date Manufacturer Received08/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2022
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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