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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 71992-01
Device Problem Device Alarm System (1012)
Patient Problems Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418); Sweating (2444); Shaking/Tremors (2515)
Event Date 09/10/2020
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 date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered 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 customer reported that due to signal loss, the low glucose alarm did not alert while wearing the adc freestyle libre 2 sensor.The customer reported experiencing sweating and shaking, and subsequently suffered a seizure and loss of consciousness.The customer was treated by the husband with an injection of glucagon for a diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.
 
Event Description
A customer reported that due to signal loss, the low glucose alarm did not alert while wearing the adc freestyle libre 2 sensor.The customer reported experiencing sweating and shaking, and subsequently suffered a seizure and loss of consciousness.The customer was treated by the husband with an injection of glucagon for a diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
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 specifications.The dhrs (device history review) for the libre sensor and sensor kit were reviewed.The dhrs showed the libre sensor and sensor kit passed all tests prior to release.If the product is returned, the case will be re-opened, and a physical investigation will be performed this serves as a correction mdr.This serves as a correction to section b2.This section was incorrectly documented in the initial mdr report.
 
Manufacturer Narrative
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 specifications.The dhrs (device history review) for the libre sensor and sensor kit were reviewed.The dhrs showed the libre sensor and sensor kit passed all tests prior to release.If the product is returned, the case will be re-opened, and a physical investigation will be performedsection h4 (device mfg date) has been updated based off on extended investigation.
 
Event Description
A customer reported that due to signal loss, the low glucose alarm did not alert while wearing the adc freestyle libre 2 sensor.The customer reported experiencing sweating and shaking, and subsequently suffered a seizure and loss of consciousness.The customer was treated by the husband with an injection of glucagon for a diagnosis of hypoglycemia.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
MDR Report Key10529207
MDR Text Key206792670
Report Number2954323-2020-06211
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71992-01
Was Device Available for Evaluation? No
Date Manufacturer Received10/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient Weight60
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