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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 Bruise/Contusion (1754); Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406)
Event Date 11/02/2022
Event Type  Injury  
Event Description
A customer reported a ¿scan again in 10 minutes¿ sensor error message with the adc device and was unable to obtain readings.As a result, customer experienced a loss of consciousness, a seizure, "fell and broke finger (left hand thumb), facial injury (abrasions, bruises)" and was unable to self-treat.Customer had contact with a healthcare professional (ambulance) who provided glucose as treatment for the diagnosis of hypoglycemia.Customer further reported having contact with a healthcare professional at a "surgical university clinic in langen" at a later date who performed an x-ray on broken thumb.No further information was provided.There was no report of death or permanent impairment associated with this event.
 
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 record) 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.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.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.Visual inspection was performed and no issues were observed on sensor patch.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.Sensor was reprogrammed and sim vivo (simulation of the electrical signal produced by the sensor tail) test was performed.All results were within specification.No malfunction or product deficiency was identified.Therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported a ¿scan again in 10 minutes¿ sensor error message with the adc device and was unable to obtain readings.As a result, customer experienced a loss of consciousness, a seizure, "fell and broke finger (left hand thumb), facial injury (abrasions, bruises)" and was unable to self-treat.Customer had contact with a healthcare professional (ambulance) who provided glucose as treatment for the diagnosis of hypoglycemia.Customer further reported having contact with a healthcare professional at a "surgical university clinic in langen" at a later date who performed an x-ray on broken thumb.No further information was provided.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
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key16070090
MDR Text Key306355371
Report Number2954323-2022-47543
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date06/30/2023
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received01/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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