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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 72079-01
Device Problem Audible Prompt/Feedback Problem (4020)
Patient Problem Loss of consciousness (2418)
Event Date 08/08/2023
Event Type  Injury  
Event Description
The customer reported an audio issue with the abbott diabetes care device.The customer reported that "they are not receiving an alarm, even though they have it set up that way".As a result, the customer experienced a loss of consciousness and was unable to self-treat.The customer reported unspecified treatment from third-party due to this issue.No further treatment details were 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 operating system is unknown so the g4 - pma/510(k) number populated is for ios.The device mfg 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
The customer reported an audio issue with the abbott diabetes care device.The customer reported that "they are not receiving an alarm, even though they have it set up that way".As a result, the customer experienced a loss of consciousness and was unable to self-treat.The customer reported unspecified treatment from third-party due to this issue.No further treatment details were provided.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 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 functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.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 reader was reviewed and the dhrs showed the fs libre reader passed all tests prior to release.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for libre sensors was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.If the partial 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
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.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
The customer reported an audio issue with the abbott diabetes care device.The customer reported that "they are not receiving an alarm, even though they have it set up that way".As a result, the customer experienced a loss of consciousness and was unable to self-treat.The customer reported unspecified treatment from third-party due to this issue.No further treatment details were provided.There was no report of death or permanent impairment associated with this event.
 
Event Description
The customer reported an audio issue with the abbott diabetes care device.The customer reported that "they are not receiving an alarm, even though they have it set up that way".As a result, the customer experienced a loss of consciousness and was unable to self-treat.The customer reported unspecified treatment from third-party due to this issue.No further treatment details were provided.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Reader (b)(6) was returned and investigated.Visual inspection was performed on the returned reader and no issues were observed.Reader was tested for volume and vibration settings and all results were within the specifications.No malfunction or product deficiency was identified.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
 
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Brand Name
FREESTYLE LIBRE 3
Type of Device
CONTINUOUS GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE LTD
range road
witney 12345 -700
UK  12345-7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key17662347
MDR Text Key322410943
Report Number2954323-2023-38286
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K212132
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 02/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number72079-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received02/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2023
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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