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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Skin Inflammation/ Irritation (4545)
Event Date 12/30/2023
Event Type  Injury  
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.The product has been requested back for an investigation.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.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.Dose audit reports were reviewed and demonstrated the continued effectiveness of the established sterilization process for libre sensor kits.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet abbott diabetes care (adc) requirements.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and freestyle 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 submitted.The device manufacturing (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
An adverse skin reaction was reported with wear of the abbott diabetes care (adc) device.Customer experienced an insertion site allergic reaction/skin irritation at the sensor site and experienced itching, red spot on their arm, and rashes all over their body and had contact with a healthcare professional (hcp) who prescribed damatol and prednisone (corticosteroid) for treatment.There was no report of death or permanent injury associated with this event.
 
Event Description
An adverse skin reaction was reported with wear of the abbott diabetes care (adc) device.Customer experienced an insertion site allergic reaction/skin irritation at the sensor site and experienced itching, red spot on their arm, and rashes all over their body and had contact with a healthcare professional (hcp) who prescribed damatol and prednisone (corticosteroid) for treatment.There was no report of death or permanent injury 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 incident are the adhesive, including the adhesive irritating the user¿s skin, or misuse, including improper site selection and repeatedly using the same application site to place the sensor.These conditions are mitigated through the freestyle product labelling.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.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.Dose audit reports were reviewed and demonstrated the continued effectiveness of the established sterilization process for libre sensor kits.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.Clinical data was reviewed and confirmed that freestyle libre sensor continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed for the reported complaint and fs libre sensors, and there were no adverse trends that indicate any potential product related issues.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.
 
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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 Key18603491
MDR Text Key334023597
Report Number2954323-2024-03627
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeCA
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
Report Date 04/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2024
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
Date Manufacturer Received04/03/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/05/2024
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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