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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRELINK; DATA MANAGEMENT SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRELINK; DATA MANAGEMENT SYSTEM Back to Search Results
Model Number 71732-01
Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 12/26/2023
Event Type  Injury  
Manufacturer Narrative
An extended investigation is pending at this time.A follow-up report will be submitted once additional information is obtained.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.
 
Event Description
A customer received an unspecified sensor error message issue on the adc device while using freestyle librelink on an a146 samsung with android operating system version 2.10.1.10406 and was unable to obtain readings.As a result, customer experienced symptoms of hypoglycemia, malaise, a loss of consciousness and was unable to self-treat.Customer had contact with a non-healthcare professional third-party (spouse)who provided sugar and coke as treatment.There was no report of death or permanent impairment associated with this event.
 
Event Description
A customer received an unspecified sensor error message issue on the adc device while using in use with a146 samsung, os 13, app version 2.10.1.10406 and was unable to obtain readings.As a result, customer experienced symptoms of hypoglycemia, malaise, a loss of consciousness and was unable to self-treat.Customer had contact with a non-healthcare professional third-party (spouse) who provided sugar and coke as treatment.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.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.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.
 
Event Description
A customer received an unspecified sensor error message issue on the adc device while using freestyle librelink on an a146 samsung with android operating system version 2.10.1.10406 and was unable to obtain readings.As a result, customer experienced symptoms of hypoglycemia, malaise, a loss of consciousness and was unable to self-treat.Customer had contact with a non-healthcare professional third-party (spouse)who provided sugar and coke as treatment.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
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 customer reported an error message was observed.Attempted to replicate the user¿s complaint using similar configuration samsung galaxy a52 (android 13, 2.10.1.10406) and was unable to reproduce the complaint and the system functioned as intended.Therefore, this complaint is not confirmed.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.The user reported receiving a "replace sensor" error message.The reported issue was investigated and attempted to replicate.The reported configuration was not compatible with the freestyle librelink app.The latest revision of the compatibility guide was available to the customer on the abbott diabetes care website 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 received an unspecified sensor error message issue on the adc device while using in use with a146 samsung, os 13, app version 2.10.1.10406 and was unable to obtain readings.As a result, customer experienced symptoms of hypoglycemia, malaise, a loss of consciousness and was unable to self-treat.Customer had contact with a non-healthcare professional third-party (spouse)who provided sugar and coke as treatment.There was no report of death or permanent impairment associated with this event.
 
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Brand Name
FREESTYLE LIBRELINK
Type of Device
DATA MANAGEMENT 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 Key18472197
MDR Text Key332372360
Report Number2954323-2024-00794
Device Sequence Number1
Product Code PZE
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P160030
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
Report Date 05/10/2024
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 Date01/31/2024
Device Model Number71732-01
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/26/2023
Initial Date FDA Received01/08/2024
Supplement Dates Manufacturer Received01/18/2024
03/27/2024
04/22/2024
Supplement Dates FDA Received01/31/2024
04/01/2024
05/10/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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