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 LTD FREESTYLE LIBRE 3; CONTINUOUS 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 LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 72081-01
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Loss of consciousness (2418); Cognitive Changes (2551)
Event Date 03/01/2024
Event Type  Injury  
Event Description
An error message was reported with the abbott diabetes care (adc) device.Customer received a "sensor error" message and was unable to obtain readings.As a result, customer experienced a loss of consciousness, "couldn't get out of bed", "their body couldn't move", "afraid" and was unable to self-treat; no third-party treatment/medication 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 manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.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.At this time product has not yet been returned for this complaint.An extended investigation has been performed for the reported complaint.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 it has been determined that there was no indication that the product did not meet specification.The device history records (dhrs) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs 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 has been performed on the returned applicator and cap; no issues were observed.Sensor cap was retained inside applicator cap.The applicator has been fired correctly.Damage was observed to the sensor cap seal indicating the user has reapplied the applicator cap after removal, but before attempting to fire the applicator.Visual inspection has been performed on the returned sensor patch; no issues were observed.Data was extracted using approved software, and extraction was successful.The returned sensor was further investigated and de-cased.Performed an internal visual inspection on the sensor¿s pcba (printed circuit board assembly); no issues were observed.Performed an smu (source measurement unit) test to ensure the sensor's electronics were functioning correctly, and the returned unit did not have any glucose reading issues.Poise voltage testing was within specification, indicating the sensor was providing accurate glucose readings.Therefore, issue is not confirmed.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.Section d4 (serial number) was updated from (b)(6) to (b)(6).All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
An error message was reported with the abbott diabetes care (adc) device.Customer received a "sensor error" message and was unable to obtain readings.As a result, customer experienced a loss of consciousness, "couldn't get out of bed", "their body couldn't move", "afraid" and was unable to self-treat; no third-party treatment/medication 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 3
Type of Device
CONTINUOUS GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE LTD
range road
witney 12345 -700
UK  12345-7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key18911049
MDR Text Key337729450
Report Number2954323-2024-08909
Device Sequence Number1
Product Code QLG
UDI-Device Identifier30357599818006
UDI-Public30357599818006
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K213132
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 04/10/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number72081-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received03/26/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
-
-