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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 71940-01
Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418); Shaking/Tremors (2515)
Event Date 11/23/2020
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 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 receiving a "replace sensor" message from the adc freestyle libre 2 sensor after 10 days of wear.As a result, the customer was unable to obtain readings and experienced trembling, seizure, and loss of consciousness.The customer was treated with glucagen injection by a third-party.There was no report of death or permanent injury associated with this event.
 
Event Description
A customer reported receiving a "replace sensor" message from the adc freestyle libre 2 sensor after 10 days of wear.As a result, the customer was unable to obtain readings and experienced trembling, seizure, and loss of consciousness.The customer was treated with glucagen injection by a third-party.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 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, a physical investigation will be performed and a follow-up report submitted.
 
Manufacturer Narrative
Sensor 3mh001pdqq0 has been returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the sensor patch.Extracted data from the returned sensor using approved software.The sensor found to be in state 5 (indicating normal termination).Inspected the plug assembly, no issues were observed.The current was applied to the sensor to perform sim vivo testing (simulation of the electrical signal produced by the sensor tail) while in the test fixture.All results were within specification.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported receiving a "replace sensor" message from the adc freestyle libre 2 sensor after 10 days of wear.As a result, the customer was unable to obtain readings and experienced trembling, seizure, and loss of consciousness.The customer was treated with glucagen injection by a third party.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 Key10924418
MDR Text Key218893903
Report Number2954323-2020-12264
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 04/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date07/31/2021
Device Model Number71940-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2020
Date Manufacturer Received03/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age44 YR
Patient Weight52
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