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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 72081-01
Device Problem Low Readings (2460)
Patient Problems Hyperglycemia (1905); Vomiting (2144)
Event Date 12/18/2023
Event Type  Injury  
Event Description
A low readings issue with the adc device was reported.Customer received unspecified low sensor scan result and experienced vomiting.Customer was unable to self-treat and was administered insulin (dose/type unspecified) by a healthcare professional for a diagnosis of hyperglycemia.No further treatment was reported.There was no report of death or permanent impairment associated with this event.A sensor result of 65 mg/dl was compared to an hcp meter reading of 501 mg/dl and the results, when plotted on a parkes error grid, fall into the "d" 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 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 and a valid serial number has not been provided.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 libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for libre sensors was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.The available tripped trend reports were reviewed for libre sensor and perception code for the last year.The review identified a tripped trend for this perception code.This tripped trend was addressed in the tracking, trending review meeting, and investigated.The investigation concluded that the tripped trend was not correlated with a product nonconformance.Trends are regularly monitored and investigated when exceeding established thresholds to evaluate for causes associated with the product.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device manufacturing 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.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.Visual inspection performed on the returned sensor patch and no issue was observed.Data was extracted using approved software and extraction was successful.The watermark was not observed at the base of the sensor tail.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 using connector key to ensure the sensor's electronics were functioning correctly and the returned unit did not have any glucose reading issues.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.Therefore, this issue is not confirmed.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.
 
Event Description
A low readings issue with the adc device was reported.Customer received unspecified low sensor scan result and experienced vomiting.Customer was unable to self-treat and was administered insulin (dose/type unspecified) by a healthcare professional for a diagnosis of hyperglycemia.No further treatment was reported.There was no report of death or permanent impairment associated with this event.A sensor result of 65 mg/dl was compared to an hcp meter reading of 501 mg/dl and the results, when plotted on a parkes error grid, fall into the "d" 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.Visual inspection performed on the returned sensor patch and no issue was observed.Data was extracted using approved software and extraction was successful.Sensor state 7 with event code 11, 224, and 227, and sensor state 8 with event code 9 are an indication that the sensor had terminated due to an intentional non-fatal error introduced by the sensor.This termination is an intended part of the sensors system and is not an indication of product non-conformance.Watermark was not observed at the base of the sensor tail.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 using connector key to ensure the sensor's electronics were functioning correctly and the returned unit did not have any glucose reading issues.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.The passing of functionality testing is an indication that there were no issues with sensor functionality and electronics therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A low readings issue with the adc device was reported.Customer received unspecified low sensor scan result and experienced vomiting.Customer was unable to self-treat and was administered insulin (dose/type unspecified) by a healthcare professional for a diagnosis of hyperglycemia.No further treatment was reported.There was no report of death or permanent impairment associated with this event.A sensor result of 65 mg/dl was compared to an hcp meter reading of 501 mg/dl and the results, when plotted on a parkes error grid, fall into the "d" 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.
 
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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 Key18458893
MDR Text Key332223329
Report Number2954323-2024-00562
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 03/12/2024
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? Yes
Device Operator Lay User/Patient
Device Model Number72081-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 12/21/2023
Initial Date FDA Received01/05/2024
Supplement Dates Manufacturer Received01/24/2024
03/11/2024
Supplement Dates FDA Received01/26/2024
03/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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