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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 High Readings (2459)
Patient Problems Hypoglycemia (1912); Dizziness (2194); Diaphoresis (2452); Shaking/Tremors (2515); Balance Problems (4401)
Event Date 06/23/2021
Event Type  Injury  
Manufacturer Narrative
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 submitted.The device manufacturing 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
A high reading issue was reported with the freestyle libre 2 sensor.A customer reported an unspecified high sensor reading and experienced symptoms of shaking, sweating, dizziness, vomiting, and was unable to walk straight.The customer had contact with a healthcare provider and was treated with dextrose via iv for diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
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).Inspected the plug assembly, no issues were observed.The current was applied to the sensor to perform linearity testing while in the test fixture.All results were within specification.No malfunction or product deficiency was identified.An extended investigation has been performed.The dhrs for the modified serial number for the libre sensor and libre sensor kit were reviewed and the dhrs showed the 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 high reading issue was reported with the freestyle libre 2 sensor.A customer reported an unspecified high sensor reading and experienced symptoms of shaking, sweating, dizziness, vomiting, and was unable to walk straight.The customer had contact with a healthcare provider and was treated with dextrose via iv for diagnosis of hypoglycemia.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 Key12208286
MDR Text Key262856274
Report Number2954323-2021-76939
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 09/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date10/31/2021
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2021
Date Manufacturer Received09/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age55 YR
Patient Weight64
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