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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 Problems Detachment of Device or Device Component (2907); Firing Problem (4011)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/28/2021
Event Type  Injury  
Manufacturer Narrative
The reported product is not expected to be returned as reporter indicated the device was discarded.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Caller reported the applicator stuck on the freestyle libre 2 sensor when it was applied to the customer's arm.No symptoms were experienced and customer was taken to a hospital where an hcp removed the device from the customer's arm.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
No product has been returned and a valid serial number has not been provided.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dose audit reports were reviewed and demonstrated the continued effectiveness of the established sterilization process for libre sensor products.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 no indication was found of any product clinical performance issues that would be expected to result or contribute to customer complaints.A tripped trend review was completed for the reported complaint and libre sensor, and there were no adverse trends that indicate any product related issues.If product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Caller reported the applicator stuck on the freestyle libre 2 sensor when it was applied to the customer's arm.No symptoms were experienced and customer was taken to a hospital where an hcp removed the device from the customer's arm.There was no report of death or permanent injury associated with this event.
 
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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
MDR Report Key11803072
MDR Text Key249928865
Report Number2954323-2021-68814
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2021
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 Received06/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age17 YR
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