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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71940-01
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Sweating (2444); Pallor (2468); Shaking/Tremors (2515)
Event Date 09/18/2019
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 nurse reported that his grandfather was unable to obtain sensor scan results on his adc freestyle libre due to an error message displayed.The grandfather subsequently experienced a hypoglycemic event, with symptoms described as pale, sweating, trembling, and slightly disturbed.The grandson, who is also his care nurse, arrived and performed a blood glucose reading with a result of 59 mg/dl and administered a glucagon injection for treatment.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Device manufactured date has been updated based on returned product download.Serial number has been updated based on the returned product.Sensor (b)(4) has been returned and investigated.Visual inspection has been performed on the returned sensor patch and no issues were observed.Extracted data from the returned sensor using approved software.Sensor found to be in sensor state 5 (indicating normal termination).The returned sensor plug was observed to be properly seated in the mount.Removed sensor plug assembly and performed a visual inspection, no issues were observed.The sensor was reprogrammed and the current was applied to perform linearity testing while in the test fixture.All results were within specification.No malfunction or product deficiency was identified.Extended investigation has also been performed.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.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.No malfunction or product deficiency was identified.
 
Event Description
A nurse reported that his grandfather was unable to obtain sensor scan results on his adc freestyle libre due to an error message displayed.The grandfather subsequently experienced a hypoglycemic event, with symptoms described as pale, sweating, trembling, and slightly disturbed.The grandson, who is also his care nurse, arrived and performed a blood glucose reading with a result of 59 mg/dl and administered a glucagon injection for treatment.There was no report of death or permanent impairment associated with this event.
 
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Brand Name
FREESTYLE LIBRE 14 DAY
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
tara williamson
1360 south loop road
alameda, CA 94502-7001
5108644472
MDR Report Key9177522
MDR Text Key161922029
Report Number2954323-2019-07787
Device Sequence Number1
Product Code PZE
Combination Product (y/n)N
PMA/PMN Number
P160030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71940-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2019
Date Manufacturer Received02/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/08/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age76 YR
Patient Weight80
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