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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)
Event Date 12/06/2020
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
An alarm issue was reported with the freestyle libre 2 sensor, customer reported the low glucose alarm did not sound and as a result, she experienced "sugar shock", seizure, and a loss of consciousness.Customer was unable to self-treat and was seen at a hospital where she was diagnosed with hypoglycemia and administered intravenous glucose.There was no report of death or permanent injury associated with this event.
 
Event Description
An alarm issue was reported.With the freestyle libre 2 sensor.Customer reported, the low glucose alarm did not sound.And as a result, she experienced "sugar shock", seizure, and a loss of consciousness.Customer was unable to self-treat.And was seen at a hospital, where she was diagnosed with hypoglycemia.And administered intravenous glucose.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.Dhrs (device history review) 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.
 
Manufacturer Narrative
Additional information: section h4 (device mfg date) was updated based on previous extended investigation.Section d3 (email) and section g1 were also updated to reflect current contact information.Sensor 3mh002a3pad has been returned and investigated.Visual inspection was performed and no issues were observed.Data was extracted from returned sensor using approved software.Sensor was found to be in state 5 (indicating normal termination).The sensor plug was properly seated in the mount.The sensor plug was removed and the plug assembly was inspected, no issues observed.The sensor¿s memory files were reviewed and confirmed that the sensor was configured correctly.The low glucose threshold in the alarm settings was set to 100 mg/dl.The sensor was activated with a retained reader and current was applied to simulate the sensor being on the body.A low glucose alarm was successfully activated, therefore this complaint is not confirmed.No malfunction or product deficiency was identified.
 
Event Description
An alarm issue was reported with the freestyle libre 2 sensor, customer reported the low glucose alarm did not sound and as a result, she experienced "sugar shock", seizure, and a loss of consciousness.Customer was unable to self-treat and was seen at a hospital where she was diagnosed with hypoglycemia and administered intravenous glucose.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 Key11030436
MDR Text Key222273725
Report Number2954323-2020-13824
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 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2021
Date Manufacturer Received03/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient Weight85
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