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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 Low Readings (2460)
Patient Problem Hyperglycemia (1905)
Event Date 04/01/2024
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation.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 low readings issue with the abbott diabetes care (adc) device was reported via email.The customer received an unspecified low sensor reading on the adc device that was lower than they felt.Due to the low readings, the customer self-treated with glucose multiple times and eventually called for an ambulance.Paramedics obtained an unspecified blood glucose reading and transported the customer to a hospital.While at the hospital, a laboratory reading of 850 mg/dl was obtained compared to a reading of 120 mg/dl on the sensor taken within 10 minutes, and the results, when plotted on a parkes error grid, fell out of range, showing the difference in values to be clinically significant.The customer was provided with insulin (2x 6 iu) and sterofundin (4x 500 ml) from a healthcare professional for treatment.The customer's blood sugar reportedly stabilized at 385 mg/dl and no further treatment was 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 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 and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.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 product is returned, a physical investigation will be performed and a follow up report will be submitted.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A low readings issue with the abbott diabetes care (adc) device was reported via email.The customer received an unspecified low sensor reading on the adc device that was lower than they felt.Due to the low readings, the customer self-treated with glucose multiple times and eventually called for an ambulance.Paramedics obtained an unspecified blood glucose reading and transported the customer to a hospital.While at the hospital, a laboratory reading of 850 mg/dl was obtained compared to a reading of 120 mg/dl on the sensor taken within 10 minutes, and the results, when plotted on a parkes error grid, fell out of range, showing the difference in values to be clinically significant.The customer was provided with insulin (2x 6 iu) and sterofundin (4x 500 ml) from a healthcare professional for treatment.The customer's blood sugar reportedly stabilized at 385 mg/dl and no further treatment was provided.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 94502-7001
5107495297
MDR Report Key19099107
MDR Text Key340051264
Report Number2954323-2024-12523
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
Report Date 04/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number72081-01
Was Device Available for Evaluation? No
Date Manufacturer Received04/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2024
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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