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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 High Readings (2459)
Patient Problems Hypoglycemia (1912); Weakness (2145); Palpitations (2467); Shaking/Tremors (2515)
Event Date 03/24/2020
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 high reading issue was reported with the freestyle libre sensor.Customer's caregiver reported unspecified high readings were obtained via sensor scan compared to unspecified readings obtained on the built-in reader.Customer experienced symptoms described as tremors, palpitations, and weakness and was treated with oral glucose by his mother.No further treatment was reported.There was no report of death or permanent injury associated with this event.
 
Event Description
A high reading issue was reported with the freestyle libre sensor.Customer's caregiver reported unspecified high readings were obtained via sensor scan compared to unspecified readings obtained on the built-in reader.Customer experienced symptoms described as tremors, palpitations, and weakness and was treated with oral glucose by his mother.No further treatment was reported.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.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.If the product is returned, a physical investigation will be performed and a follow-up report submitted.
 
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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
MDR Report Key9948447
MDR Text Key187232767
Report Number2954323-2020-02626
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 consumer
Type of Report Initial,Followup
Report Date 05/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2020
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? No
Date Manufacturer Received05/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age9 YR
Patient Weight30
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