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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 Low Readings (2460)
Patient Problems Fatigue (1849); Nausea (1970); Pain (1994); Vomiting (2144); Diabetic Ketoacidosis (2364)
Event Date 02/04/2024
Event Type  Injury  
Event Description
A low readings issue with the adc device was reported.Customer received unspecified low sensor scan results and experienced symptoms described as nausea, vomiting, general pain, light sensitivity, and fatigue.Customer was unable to self-treat and had contact with a healthcare professional where a reading of 400mg/dl was obtained on their meter.Customer was treated with an insulin drip, dextrose fluids, and pain management medication for a diabetic ketoacidosis (dka) diagnosis.No further treatment was reported.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on sensor and no issues were observed.The sensor plug was seated in mount properly.Data was successfully extracted from the returned sensor using approved software.Removed the sensor plug and inspected the plug assembly, no failure mode observed.Current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Sensor was reprogrammed and simvivo test performed.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.Therefore, the issue is not confirmed.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A low readings issue with the adc device was reported.Customer received unspecified low sensor scan results and experienced symptoms described as nausea, vomiting, general pain, light sensitivity, and fatigue.Customer was unable to self-treat and had contact with a healthcare professional where a reading of 400mg/dl was obtained on their meter.Customer was treated with an insulin drip, dextrose fluids, and pain management medication for a diabetic ketoacidosis (dka) diagnosis.No further treatment was reported.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.No malfunction or product deficiency was identified.This serves as a correction report.Section h10 (addtl mfg narrative) was incorrectly documented in the previous report.Correction has been made.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 Key18808697
MDR Text Key336574114
Report Number2954323-2024-07237
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 02/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2024
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? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2024
Date Manufacturer Received02/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2023
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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