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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 Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Diaphoresis (2452); Shaking/Tremors (2515); Convulsion/Seizure (4406)
Event Date 03/05/2024
Event Type  Injury  
Event Description
A "replace sensor" error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced heavy sweating, shaking hands, seizure, and a loss of consciousness and was unable to self-treat, requiring third-party administration of chocolate for treatment.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.The customer¿s product has been requested for 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.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) was returned and investigated.The sensor plug was properly seated and no physical damage was observed on the sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 6 (indicating abnormal termination) with a brownout reset event internally logged (event 21).Performed a visual inspection on the sensor plug; no failure modes were observed.The returned sensor was further investigated and de-cases.Performed an internal visual inspection on the sensor¿s pcba (printed circuit board assembly); no issues were observed.Measured the battery and voltage observed to be dropping.Removed the battery from the battery holder revealed clouding on the negative contact of the battery.The salt formation in the crack of the battery gasket between the positive and negative contact was also observed.Therefore, this issue is confirmed due to battery failed seal leak.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A "replace sensor" error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced heavy sweating, shaking hands, seizure, and a loss of consciousness and was unable to self-treat, requiring third-party administration of chocolate for treatment.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 94502 7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda 94502-7001
5107495297
MDR Report Key18927550
MDR Text Key337943783
Report Number2954323-2024-09148
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeHR
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 05/01/2024
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 03/05/2024
Initial Date FDA Received03/19/2024
Supplement Dates Manufacturer Received04/06/2024
Supplement Dates FDA Received05/01/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2023
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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