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); Discomfort (2330)
Event Date 12/21/2023
Event Type  Injury  
Event Description
A high reading issue was reported with the adc device.It was reported that the customer reported receiving unspecified high sensor readings compared to unspecified readings from built-in precision meter.As a result, the customer experienced paleness and discomfort and was unable to self-treat.The customer was in contact with a healthcare professional (hcp) who provided the customer with three (3) sweet candies as treatment.No further treatment or medication was reported.There was no report of death or permanent impairment associated with this event.A sensor result of 460 mg/dl was compared to a built-in reader reading of 40 mg/dl and the results, when plotted on a parkes error grid, fall into the "e" zone, showing the difference in values to be clinically significant.It is unknown when these readings were obtained in relation to the reported adverse 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 and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for freestyle libre sensors was reviewed and showed no anomalies or non-conformances that could have led to the complaint.A tripped trend review was conducted for the reported complaint and freestyle libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A high reading issue was reported with the adc device.It was reported that the customer reported receiving unspecified high sensor readings compared to unspecified readings from built-in precision meter.As a result, the customer experienced paleness and discomfort and was unable to self-treat.The customer was in contact with a healthcare professional (hcp) who provided the customer with three (3) sweet candies as treatment.No further treatment or medication was reported.There was no report of death or permanent impairment associated with this event.A sensor result of 460 mg/dl was compared to a built-in reader reading of 40 mg/dl and the results, when plotted on a parkes error grid, fall into the "e" zone, showing the difference in values to be clinically significant.It is unknown when these readings were obtained in relation to the reported adverse 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 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.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.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.All pertinent information available to abbott diabetes care has been submitted.
 
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 Key18447620
MDR Text Key332152100
Report Number2954323-2024-00313
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeFR
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 02/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received01/30/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-