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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 Hypoglycemia (1912); Diaphoresis (2452); Confusion/ Disorientation (2553)
Event Date 05/14/2023
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.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A battery/no power issue was reported with the adc device reader.Customer was unable to test due to the reader not powering on with button press or test strip insertion and as a result, experienced paleness, cold sweats, delayed reaction, and disorientation.The customer was unable to self-treat, requiring treatment with glucagon provided by a non-healthcare professional (non-hcp).There were no reports of treatment by a healthcare professional (hcp).There was no report of death or permanent impairment associated with this event.
 
Event Description
A battery/no power issue was reported with the adc device reader.Customer was unable to test due to the reader not powering on with button press or test strip insertion and as a result, experienced paleness, cold sweats, delayed reaction, and disorientation.The customer was unable to self-treat, requiring treatment with glucagon provided by a non-healthcare professional (non-hcp).There were no reports of treatment by a healthcare professional (hcp).There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Reader (b)(6) has been returned and investigated.Visual inspection has been performed for the reader and damage was observed due to user related issue.Visual inspection was performed on usb port and usb/charging cable and damage was observed.The damaged usb port would prevent the customer from charging the reader which would lead to the reader not turning on.The returned reader was de-cased.Visual inspection has been performed on the returned reader and observed returned reader to be in poor condition due to use.Contamination was observed inside the charging port which prevents the reader from charging and communicating with pc.Visual inspection was performed on the returned charging cable and contamination was observed in the end of the returned charging cable which prevents the micro usb end of the cable to be inserted correctly.The returned adapter is not the supplied adapter and is a nokia phone charging adapter.Therefore this issue is not confirmed to use.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 and verification of correct cable and adapter were reviewed.The dhrs showed that the libre reader passed all tests prior to release and the correct cable and adapter were part of the kit pack.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 Key17028032
MDR Text Key316191454
Report Number2954323-2023-22623
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 08/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2023
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 Received08/11/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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