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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 Fatigue (1849); Hypoglycemia (1912); Vomiting (2144); Loss of consciousness (2418); Convulsion/Seizure (4406)
Event Date 01/07/2024
Event Type  Injury  
Event Description
An alarm issue was reported with the adc device.A caregiver reported that the customer's sensor failed to alarm when their blood glucose was low and as a result, the customer experienced vomiting, fatigue, a seizure, and a loss consciousness.The customer's mother administered baqsimi and then seen at a hospital where intravenous glucose, nasal powder, ibuprofen, and "nolotil" was provided for treatment.No further information 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 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.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.Freestyle librelink complaint was investigated and no issues with the librelink application was determined that would have led to the complaint.The user reported signal loss alarm with the freestyle librelink application.Attempted to replicate the issue using similar device configuration and was not able to reproduce the complaint.Thus, this complaint is not confirmed.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.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and sensor kit were reviewed, and the dhrs showed the 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 was properly seated and no physical damage is observed on the sensor patch.Data was extracted from the returned sensor using approved software.Sensor found to be in state 1 (storage state) no failure modes were observed on the sensor plug assembly upon visual inspection.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
An alarm issue was reported with the adc device.A caregiver reported that the customer's sensor failed to alarm when their blood glucose was low and as a result, the customer experienced vomiting, fatigue, a seizure, and a loss consciousness.The customer's mother administered baqsimi and then seen at a hospital where intravenous glucose, nasal powder, ibuprofen, and "nolotil" was provided for treatment.No further information was reported.There was no report of death or permanent impairment associated with this event.
 
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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
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key18592149
MDR Text Key333893346
Report Number2954323-2024-03452
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeSP
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 02/09/2024
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? No
Device Operator Lay User/Patient
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 01/08/2024
Initial Date FDA Received01/26/2024
Supplement Dates Manufacturer Received01/28/2024
Supplement Dates FDA Received02/09/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/13/2023
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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