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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); Nausea (1970); Vomiting (2144)
Event Date 12/09/2023
Event Type  Injury  
Event Description
A customer reported receiving a "replace sensor" message from the adc device.As a result, the customer was unable to obtain readings while they felt hypoglycemic and experienced nausea and vomiting.The customer was administered juice and insulin injection (dose/type unknown) for treatment by a non-healthcare professional.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.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported receiving a "replace sensor" message from the adc device in use with samsung galaxy a23, android 13, app version 2.10.1.10406.As a result, the customer was unable to obtain readings while they felt hypoglycemic and experienced nausea and vomiting.The customer was administered juice and insulin injection (dose/type unknown) for treatment by a non-healthcare professional.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.The freestyle librelink app complaint was investigated and determined that there were no issues with the librelink application that would have led to the complaint.The user reported for an error message and no readings were obtain.Attempted to replicate the user¿s complaint using similar configurations and the user complaint could not be replicated and the system functioned as intended.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 it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits 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.This also serves as a correction report.Section h10 (addtl mfg narrative) was incorrectly documented in the previous report.Correction has been made.
 
Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.The freestyle libre 2 complaint was investigated and determined that there were no issues with the libre 2 application that would have led to the complaint.The user reported error code 365.Attempted to replicate the user¿s complaint using similar configuration of samsung galaxy a52, android 13, 2.10.1.10406 and the reported issue was unable to be replicated and the system functioned as intended.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
A customer reported receiving a "replace sensor" message from the adc device in use with samsung galaxy a23, android 13, app version 2.10.1.10406.As a result, the customer was unable to obtain readings while they felt hypoglycemic and experienced nausea and vomiting.The customer was administered juice and insulin injection (dose/type unknown) for treatment by a non-healthcare professional.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 Key18387091
MDR Text Key331287963
Report Number2954323-2023-55009
Device Sequence Number1
Product Code QLG
UDI-Device Identifier05021791003006
UDI-Public(01)05021791003006(17)250131(10)7281517(91)71995-01
Combination Product (y/n)N
Reporter Country CodeTU
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
Report Date 04/04/2024
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? No
Initial Date Manufacturer Received 12/13/2023
Initial Date FDA Received12/22/2023
Supplement Dates Manufacturer Received01/07/2024
03/21/2024
Supplement Dates FDA Received01/17/2024
04/04/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2023
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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