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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 Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Seizures (2063); Shaking/Tremors (2515)
Event Date 10/30/2020
Event Type  Injury  
Manufacturer Narrative
The reported product is not expected to be returned as the customer discarded the product.A follow-up report will be filed if product is returned or additional information is obtained.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
Customer reported receiving a "scan again in 10 min" message after 2 days of wearing the adc freestyle libre 2 sensor.Customer experienced symptoms of hypoglycemia described as "trembling, could no longer hold on to his legs" and seizures.Paramedics was called and customer received unspecified treatment for the diagnosis of hypoglycemia.There was no report of death or permanent impairment 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 specification.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.If the product is returned, the case will be re-opened, and a physical investigation will be performed.
 
Event Description
Customer reported receiving a "scan again in 10 min" message after 2 days of wearing the adc freestyle libre 2 sensor.Customer experienced symptoms of hypoglycemia described as "trembling, could no longer hold on to his legs" and seizures.Paramedics was called and customer received unspecified treatment for the diagnosis of hypoglycemia.There was no report of death or permanent impairment 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 Key10853231
MDR Text Key216652784
Report Number2954323-2020-11015
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 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date09/30/2021
Device Model Number71992-01
Was Device Available for Evaluation? No
Date Manufacturer Received12/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age58 YR
Patient Weight90
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