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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 Device Alarm System (1012); Application Program Problem (2880)
Patient Problems Loss of consciousness (2418); Convulsion/Seizure (4406)
Event Date 09/05/2023
Event Type  Injury  
Event Description
An alarm issue was reported with the adc device in use with iphone 7 phone with ios operating system version 16.6.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced a seizure and a loss of consciousness.No treatment was reported, and no further information was provided.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.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
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.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.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.
 
Event Description
An alarm issue was reported with the adc device in use with iphone 7 phone with ios operating system version 16.6.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced a seizure and a loss of consciousness.No treatment was reported, and no further information was provided.There was no report of death or permanent impairment associated with this event.
 
Event Description
An alarm issue was reported with the adc device in use with iphone 7 phone with ios operating system version 16.6 and app version 2.8.1.6120.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced a seizure and a loss of consciousness.No treatment was reported, and no further information was provided.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the sensor patch.The sensor was found to be in state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The reported sensor was activated with a known good reader.Incompatible sensor message was observed.The sensor was unable to be activated for linearity test.An extended investigation was performed.Attempted to scan the returned sensor, however, no patch detected was observed.The returned sensor was de-cased to replace the returned battery with a known good battery.The sensor was reprogrammed and activated with a known good reader.Linearity testing was performed and waited for the readings to generate on the known good reader.Both high and low glucose alarms were successfully activated.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
 
Manufacturer Narrative
An additional investigation has been conducted.Sensor (b)(6)has been returned and investigated.A visual inspection was performed and no physical damage is observed on sensor patch.Sensor plug was properly seated in the mount.Extracted data from returned sensor using approved software.Sensor 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 returned sensor was de-cased and the returned battery was measured to be low voltage.However the battery voltage was not a contributing factor to customer complaint.The returned battery was then replaced with a new unused battery.The sensor was activated with a new un-used reader, and an accuracy test was performed; all results were with in specification.Both high and low glucose alarms were successfully activated.No malfunction or product deficiency was identified; therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.Section d4 (udi) has been updated as this information was not submitted in the previous report.
 
Event Description
An alarm issue was reported with the adc device in use with iphone 7 phone with ios operating system version 16.6 and app version 2.8.1.6120.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced a seizure and a loss of consciousness.No treatment was reported, and no further information was provided.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
This serves as a correction as the section g3 for the mfg report 2954323-2023-42382 follow-up 3 was incorrect.
 
Event Description
An alarm issue was reported with the adc device in use with iphone 7 phone with ios operating system version 16.6 and app version 2.8.1.6120.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced a seizure and a loss of consciousness.No treatment was reported, and no further information was provided.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 Key17816317
MDR Text Key324224099
Report Number2954323-2023-42382
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeAS
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,Followup,Followup,Followup
Report Date 05/03/2024
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 Expiration Date02/29/2024
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 09/05/2023
Initial Date FDA Received09/26/2023
Supplement Dates Manufacturer Received10/11/2023
02/07/2024
03/01/2024
05/03/2024
Supplement Dates FDA Received10/27/2023
02/20/2024
04/04/2024
05/03/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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