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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 Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 01/19/2023
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 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.
 
Event Description
A battery/no power issue was reported with the adc device.Customer was unable to obtain readings.As a result, the customer experienced a loss of consciousness and required hcp treatment of iv glucose there was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has 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
A battery/no power issue was reported with the adc device.Customer was unable to obtain readings.As a result, the customer experienced a loss of consciousness and required hcp treatment of iv glucose there was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Reader (b)(6) has been returned and investigated.The reader was visually inspected and observed damaged usb port.The damaged usb port would prevent the customer from charging the reader which would lead to the reader not turning on.Visually inspected the returned usb charger and usb cable and no damage was observed.Performed load test on the usb charger and results were within specification range.Visual inspection has been performed on the power adapter and no issues were observed.The power adapter voltage was measured to be within specification range (4.75v-5.25v).The reader was further de-cased and placed into the reader test fixture to download log.Reader log was unable to be downloaded due to damaged usb port.Therefore, issue is not confirmed to use due to damaged usb port.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A battery/no power issue was reported with the adc device.Customer was unable to obtain readings.As a result, the customer experienced a loss of consciousness and required hcp treatment of iv glucose 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
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key17318059
MDR Text Key319010745
Report Number2954323-2023-30232
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 03/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71953-01
Device Catalogue Number71952
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received02/28/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
Patient SexMale
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