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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); Sweating (2444)
Event Date 11/09/2020
Event Type  Injury  
Manufacturer Narrative
At this time product has not yet been returned and abbot diabetes care product quality engineering (pqe) investigated the alarm-3 (missing high or low glucose) complaint.The serial number of the freestyle libre 2 sensor associated with this complaint is unknown.During investigation of the track and trend review related to alarm-3 cases in april 2020 this failure mode was identified and is a known manufacturing issue that impacts libre 2 sensors manufactured at flex buffalo grove (fbg).As the serial number of the sensor associated with this complaint is unknown, pqe is unable to determine if the sensor is impacted by this manufacturing issue.Outside of the known manufacturing issue, the available tripped trend reports for libre 2 sensor and alarm-3 have been reviewed.The review did not identify any additional trends that would indicate a product related issue related to this complaint.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, the case will be re-opened, and a physical investigation will be performed.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 use of the adc freestyle libre 2 sensor.A customer reported that the low glucose alarm did not sound and experienced symptoms described as cold-sweating, non-responsive, seizure, and loss of consciousness.The customer had contact with a healthcare provider who diagnosed her with hypoglycemia and customer was treated with glucose injection.There was no report of death or permanent injury associated with this event.
 
Event Description
An alarm issue was reported with the use of the adc freestyle libre 2 sensor.A customer reported that the low glucose alarm did not sound and experienced symptoms described as cold-sweating, non-responsive, seizure, and loss of consciousness.The customer had contact with a healthcare provider who diagnosed her with hypoglycemia and customer was treated with glucose injection.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
The reader associated with this case (magy325-j3505) was returned and investigated.Visual inspection was performed on the returned reader and no issues were observed.The event log was downloaded and the glucose value graph was analyzed.All alarms presented were for glucose values outside of the threshold range.No malfunction or product deficiency was identified.Section d3 (email) and section g1 were updated to reflect current contact information.All pertinent information available to abbott diabetes care has been submitted.
 
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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 Key11030729
MDR Text Key222274570
Report Number2954323-2020-13827
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 05/13/2021
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 Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2021
Date Manufacturer Received04/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
Patient Weight72
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