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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); Hot Flashes/Flushes (2153); Loss of consciousness (2418); Diaphoresis (2452); Shaking/Tremors (2515)
Event Date 12/15/2022
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 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.
 
Event Description
A webform complaint was received in which an error message was reported with the adc device.Customer received a "sensor ended message" and was unable to obtain readings.As a result, customer experienced symptoms of hot, sweaty, cold, and loss of consciousness.When customer woke up, they went to the kitchen to get something to eat but was still shaking.No further details were reported.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 6 (indicating early termination).Inspected the plug assembly, no issues were observed.The sensor state was reprogramed and activated and it went to state 6(please write the meaning ).Issue was further de-cased and battery was replaced.Sim vivo testing (simulation of the electrical signal produced by the sensor tail) was performed and all results were within specification.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A webform complaint was received in which an error message was reported with the adc device.Customer received a "sensor ended message" and was unable to obtain readings.As a result, customer experienced symptoms of hot, sweaty, cold, and loss of consciousness.When customer woke up, they went to the kitchen to get something to eat but was still shaking.No further details were reported.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 Key16132329
MDR Text Key307020251
Report Number2954323-2023-01577
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeUK
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 02/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date12/31/2023
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 12/17/2022
Initial Date FDA Received01/10/2023
Supplement Dates Manufacturer Received01/30/2023
Supplement Dates FDA Received02/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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