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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 Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Headache (1880); Hypoglycemia (1912); Hot Flashes/Flushes (2153); Malaise (2359); Loss of consciousness (2418); Convulsion/Seizure (4406)
Event Date 01/24/2022
Event Type  Injury  
Manufacturer Narrative
Sensor kit expiration date is 30-apr-2021.The medical event associated with this complaint occurred on (b)(6) 2022 which indicates usage of the device beyond the useful lifespan.No additional investigations are required as the sensor was expired at the time of use, and the device met its specification lifespan.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
A customer reported a sensor error message upon scanning the freestyle libre 2 sensor.The customer was unable to obtain sensor scans and experienced symptoms of hypoglycemia described as ¿heat, malaise, headaches, out of phase, the patient no longer remembers¿.The customer was transported to the hospital where she was hospitalized and orange juice was provided as treatment.While in the hospital, 2 additional sensors were applied to the customer however, the sensors contributed to unspecified issues (didn¿t work ) and the customer experienced symptoms of a seizure and a loss of consciousness.The customer was kept for observation in the hospital for a week and no further information was provided.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Sensor kit expiration date is 30-apr-2021.The medical event associated with this complaint occurred on (b)(6) 2022 which indicates usage of the device beyond the useful lifespan.No additional investigations are required as the sensor was expired at the time of use, and the device met its specification lifespan.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
A customer reported a sensor error message upon scanning the freestyle libre 2 sensor.The customer was unable to obtain sensor scans and experienced symptoms of hypoglycemia described as ¿heat, malaise, headaches, out of phase, the patient no longer remembers¿.The customer was transported to the hospital where she was hospitalized and orange juice was provided as treatment.While in the hospital, 2 additional sensors were applied to the customer however, the sensors contributed to unspecified issues (didn¿t work ) and the customer experienced symptoms of a seizure and a loss of consciousness.The customer was kept for observation in the hospital for a week and no further information was provided.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
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key13509850
MDR Text Key285460881
Report Number2954323-2022-04680
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeFR
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 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/30/2021
Device Model Number71992-01
Was Device Available for Evaluation? No
Date Manufacturer Received01/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/24/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient SexFemale
Patient Weight60 KG
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