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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 72081-01
Device Problem Material Twisted/Bent (2981)
Patient Problem Loss of consciousness (2418)
Event Date 01/11/2024
Event Type  Injury  
Event Description
A bent sensor tip was reported with the adc device and customer was therefore unable to apply the device and monitor glucose levels.As a result, the customer experienced a loss of consciousness; however, after regaining consciousness the customer was able to self-treat with unspecified hypertension medication.After an unknown amount of time, the customer presented at their doctor's office and an x-ray was obtained but no further treatment was indicated.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 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.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 determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and sensor kit were reviewed, and the dhrs showed the 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.The date the incident occurred is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Manufacturer Narrative
Sensor (b)(6)has been returned and investigated.Performed a visual inspection on the returned product and factory-sealed applicator was observed.Applicator was opened and visual inspection was performed on the returned product.Applicator did not fire.Sensor was observed to be stuck in an unfired applicator and puck carrier was locked in place.Visual inspection has been performed on both sharp and sensor and no issues were observed.Therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A bent sensor tip was reported with the adc device and customer was therefore unable to apply the device and monitor glucose levels.As a result, the customer experienced a loss of consciousness; however, after regaining consciousness the customer was able to self-treat with unspecified hypertension medication.After an unknown amount of time, the customer presented at their doctor's office and an x-ray was obtained but no further treatment was indicated.There was no report of death or permanent impairment associated with this event.
 
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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 Key18646426
MDR Text Key334609451
Report Number2954323-2024-04296
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K223435
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 03/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number72081-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received02/25/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/24/2023
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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