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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 High Readings (2459)
Patient Problems Hypoglycemia (1912); Seizures (2063); Dizziness (2194); Loss of consciousness (2418); Sweating (2444); Shaking/Tremors (2515)
Event Date 11/19/2020
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 device manufacturing 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 caller reported a high reading issue with the freestyle libre 2 sensor, on behalf of a customer.The caller reported a scan reading of 129 mg/dl compared to a competitor blood glucose meter of 59 mg/dl.The customer experienced symptoms of dizziness, trembling, sweating, discomfort, cramping, seizure, and loss of consciousness.The customer had contact with a healthcare professional, who diagnosed the customer with hypoglycemia, and provided 500 ml of glucose solution via iv.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
No product has been returned.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 sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit 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 caller reported a high reading issue with the freestyle libre 2 sensor, on behalf of a customer.The caller reported a scan reading of 129 mg/dl compared to a competitor blood glucose meter of 59 mg/dl.The customer experienced symptoms of dizziness, trembling, sweating, discomfort, cramping, seizure, and loss of consciousness.The customer had contact with a healthcare professional, who diagnosed the customer with hypoglycemia, and provided 500 ml of glucose solution via iv.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 Key10945400
MDR Text Key219491833
Report Number2954323-2020-12756
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
Report Date 12/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/31/2022
Device Model Number71992-01
Was Device Available for Evaluation? No
Date Manufacturer Received12/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
Patient Weight59
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