Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71992-01
Device Problem High Readings (2459)
Patient Problems Hypoglycemia (1912); Hot Flashes/Flushes (2153); Dizziness (2194)
Event Date 10/04/2023
Event Type  Injury  
Event Description
A high readings issue with the adc device was reported.The customer reportedly obtained a sensor reading of 13.6 mmol/l that was higher than they felt and self-treated with two units of insulin (type unknown).The customer then experienced symptoms of hypoglycemia, dizziness and hot flashes.As a result, the customer was unable to self-treat and required treatment of coca-cola by a third-party.No further treatment was reported.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle 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.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 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A high readings issue with the adc device was reported.The customer reportedly obtained a sensor reading of 13.6 mmol/l that was higher than they felt and self-treated with two units of insulin (type unknown).The customer then experienced symptoms of hypoglycemia, dizziness and hot flashes.As a result, the customer was unable to self-treat and required treatment of coca-cola by a third-party.No further treatment was reported.There was no report of death or permanent impairment associated with this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18005432
MDR Text Key326519844
Report Number2954323-2023-47166
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeCA
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 02/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2023
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 Manufacturer Received01/29/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-