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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 Fall (1848); Hematoma (1884); Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406)
Event Date 11/26/2020
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation.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
A husband reported on social media, on behalf of his wife, regarding high readings with an adc freestyle libre 2 sensor.The wife was reported to have gestational diabetes and insulin resistance.On (b)(6) 2020 a sensor scan of 189 mg/dl was obtained as compared to a blood glucose of 162 mg/dl on an unknown blood glucose meter, taken immediately afterwards.The wife self-treated with 15 units of insulin (pen) and subsequently experienced a seizure, turning blue, foaming at the mouth, and unresponsive.Emergency services were called and a blood glucose of 43 mg/dl was obtained on the paramedic meter, compared to a sensor scan of 85 mg/dl.The customer was taken to the hospital and provided an unknown treatment for the medical event, and cesarean birth was performed.As a result of the customer's medical event, it was reported the customer experienced no sense of taste or smell, deafness in the left ear, and a large hematoma that required surgical removal.No further information was reported.There was no report of death or permanent injury associated with this event.
 
Event Description
A husband reported on social media, on behalf of his wife, regarding high readings with an adc freestyle libre 2 sensor.The wife was reported to have gestational diabetes and insulin resistance.On (b)(6) 2020 a sensor scan of 189 mg/dl was obtained as compared to a blood glucose of 162 mg/dl on an unknown blood glucose meter, taken immediately afterwards.The wife self-treated with 15 units of insulin (pen) and subsequently experienced a seizure, turning blue, foaming at the mouth, and unresponsive.Emergency services were called and a blood glucose of 43 mg/dl was obtained on the paramedic meter, compared to a sensor scan of 85 mg/dl.The customer was taken to the hospital and provided an unknown treatment for the medical event, and cesarean birth was performed.As a result of the customer's medical event, it was reported the customer experienced no sense of taste or smell, deafness in the left ear, and a large hematoma that required surgical removal.No further information was reported.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.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.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
MDR Report Key11098596
MDR Text Key224523802
Report Number2954323-2020-14660
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 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
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 Received01/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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