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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 09/11/2020
Event Type  Injury  
Manufacturer Narrative
At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and sensor kit were reviewed, and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.The dhrs (device history review) for the libre reader were reviewed, and the dhrs showed the libre reader 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
Customer reported receiving a "signal loss" and low glucose alarm did not sound while wearing an adc freestyle libre 2 sensor.Customer further reported that he "fell into coma" and experienced seizure and loss of consciousness.Customer had contact with healthcare provider who diagnosed him with hypoglycemia and received intravenous glucose for treatment.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Sensor (b)(6) and reader (b)(6) have been returned and investigated.Visual inspection was performed on the returned sensor and reader, 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 were observed.The sensor was activated with the returned reader and the bluetooth connection was successful.Linearity test was performed while the reader was wrapped in aluminum foil (to simulate signal loss), signal loss message was observed.Since the sensor and reader communicated successfully and a signal loss message was observed after simulating a signal loss, the combination of returned sensor and reader were found to be functioning properly; therefore this complaint is not confirmed.No malfunction or product deficiency was identified.Section d3 (email) and section g1 have been updated to reflect current contact information.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported receiving a "signal loss" and low glucose alarm did not sound while wearing an adc freestyle libre 2 sensor.Customer further reported that he "fell into coma" and experienced seizure and loss of consciousness.Customer had contact with healthcare provider who diagnosed him with hypoglycemia and received intravenous glucose for treatment.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 Key10603926
MDR Text Key209121281
Report Number2954323-2020-06682
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 03/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2020
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 Manufacturer10/30/2020
Date Manufacturer Received03/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age61 YR
Patient Weight103
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