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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); Unable to Obtain Readings (1516); Battery Problem (2885)
Patient Problems Hypoglycemia (1912); Tachycardia (2095); Loss of consciousness (2418); Diaphoresis (2452); Confusion/ Disorientation (2553)
Event Date 06/23/2022
Event Type  Injury  
Manufacturer Narrative
At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre reader was reviewed and the dhrs showed the fs 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 complaint was received regarding unknown battery issues while using the adc device in which the device turned off upon use.As a result, on (b)(6) 2022, the customer experienced confusion, sweating, panicking, tachycardia, and a loss of consciousness and was provided orange juice by a non-healthcare professional for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
The returned reader was investigated.Reader does turn on with button press.Issue could not be reproduced.Observed damaged speaker wires while performing bnp-2 investigation.Therefore issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A complaint was received regarding unknown battery issues while using the adc device in which the device turned off upon use.As a result, on (b)(6) 2022, the customer experienced confusion, sweating, panicking, tachycardia, and a loss of consciousness and was provided orange juice by a non-healthcare professional for treatment.No further information was provided.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 Key14854116
MDR Text Key294933808
Report Number2954323-2022-21686
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeUK
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 07/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2022
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 Received07/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2020
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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