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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 Premature Discharge of Battery (1057)
Patient Problems Fatigue (1849); Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 11/17/2023
Event Type  Injury  
Event Description
A battery/power issue was reported with the abbott diabetes care (adc) device.Customer reported being unable to test due to a fast draining battery.As a result, customer experienced a loss of consciousness, "feeling weak", "balance was not good", and upon waking performed a blood glucose measurement with result of "40 something" mg/dl, prior to self-treating with "eating a bunch of candy." there was no report of death or permanent injury 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 device history review (dhrs) 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 of event is unknown.The date entered in section b3 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/power issue was reported with the abbott diabetes care (adc) device.Customer reported being unable to test due to a fast draining battery.As a result, customer experienced a loss of consciousness, "feeling weak", "balance was not good", and upon waking performed a blood glucose measurement with result of "40 something" mg/dl, prior to self-treating with "eating a bunch of candy." there was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the returned reader and no issues were observed.Reader was sufficiently charged.De-cased the reader and no issues were observed upon visual inspection.Performed power consumption test and all results were within specifications.An extended investigation has been performed on the reader.Visual inspection has been performed on the returned reader and no issues were observed.Reader powered on with button depression and the battery was sufficiently charged.An off current test was performed and the current draw on the returned reader was within specification.Therefore, issue is not confirmed.An investigation has been performed for the reported complaint.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.In addition, the review determined that the correct cable and adapter were part of the reader kit pack and there was no indication that the product did not meet specifications.The customer did not return the usb charging cable and adapter.If partial product is returned, the case will be re-opened, and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
 
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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 Key18214856
MDR Text Key329062863
Report Number2954323-2023-51645
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
Report Date 02/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2023
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 Received01/24/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
Patient SexMale
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