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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 Problem Hypoglycemia (1912)
Event Date 10/17/2023
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/power issue was reported with the adc device.Customer reported being unable to test due to a fast draining battery and as a result, felt "lost their senses".Customer was provided with water, sugar, fruit juice and baqsimi nasal spray via non-healthcare professional.No further treatment was required.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 usb/charging cable, no issues were observed.Reader was sufficiently charged.Event log was downloaded and checked for cybersecurity event code and none was observed.Power consumption test was performed and was within specification.No malfunction or product deficiency has been identified.Issue is not confirmed due to fast draining battery not observed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A battery/power issue was reported with the adc device.Customer reported being unable to test due to a fast draining battery and as a result, felt "lost their senses".Customer was provided with water, sugar, fruit juice and baqsimi nasal spray via non-healthcare professional.No further treatment was required.There was no report of death or permanent injury 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 was 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.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/power issue was reported with the adc device.Customer reported being unable to test due to a fast draining battery and as a result, felt "lost their senses".Customer was provided with water, sugar, fruit juice and baqsimi nasal spray via non-healthcare professional.No further treatment was required.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 Key18022470
MDR Text Key326745765
Report Number2954323-2023-47515
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeIT
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 12/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2023
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 Received12/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2022
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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