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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); Pallor (2468)
Event Date 10/29/2019
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 in section 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 readings issue was reported with use of the adc freestyle libre sensor.On (b)(6) 2019, customer experienced symptoms of hypoglycemia described as weakness, pallor and nervousness at 6:18 p.M.And received an unspecified high reading on the sensor.Customer was treated with sugar and food by a non hcp.Customer additionally reported sensor scan result of 224 mg/dl compared to a reading of 107 mg/dl obtained on the built-in at 9:15 p.M.There was no report of death or permanent impairment 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.
 
Event Description
A high readings issue was reported with use of the adc freestyle libre sensor.On (b)(6) 2019, customer experienced symptoms of hypoglycemia described as weakness, pallor and nervousness at 6:18 p.M.And received an unspecified high reading on the sensor.Customer was treated with sugar and food by a non hcp.Customer additionally reported sensor scan result of 224 mg/dl compared to a reading of 107 mg/dl obtained on the built-in at 9:15 p.M.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
MDR Report Key9292463
MDR Text Key165579232
Report Number2954323-2019-08713
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 03/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
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? No
Date Manufacturer Received03/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient Weight73
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