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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71702-01
Device Problem High Readings (2459)
Patient Problems Hypoglycemia (1912); Seizures (2063); Cramp(s) (2193)
Event Date 09/14/2018
Event Type  Injury  
Manufacturer Narrative
The customer's products have been requested for investigation.A follow-up report will be filed once the product is returned or additional information is obtained.The date of manufacture is unknown.The date listed in section is the date when abbott diabetes care became aware of the event all pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported receiving a high reading from her adc freestyle libre sensor.It was further reported that on (b)(6) 2018 she received a ¿hi¿ (a reading greater than 500 mg/dl) on her sensor so she self-administered insulin to decrease the glucose.The sensor continued to read ¿hi¿ so she again injected insulin, but then she started ¿cramping, was hypoglycemic¿ and then had a seizure.Paramedics were called and customer was transported to a hospital where she was diagnosed with hypoglycemia and admitted.Customer could not recall the specific treatment provided at the hospital.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Additional information: (device mfg date) has been updated.The reported sensor was returned and investigated.Visual inspection has been performed on the returned sensor patch and no issues were observed.The sensor plug was properly seated in the mount.Removed the plug and inspected the plug assembly, observed that the sensor neck to have a crack across the width and through the carbon layer.Extracted data from returned sensor using approved software.Sensor found to be in state 5 (normal termination).Sensor inserted into the sim-vivo test fixture.Sensor was reprogrammed and applied current to perform linearity testing.Although a crack was observed on the sensors neck, all results were within specification.No product deficiency was identified.The complaint is not confirmed.
 
Event Description
Customer reported receiving a high reading from her adc freestyle libre sensor.It was further reported that on (b)(6) 2018 she received a ¿hi¿ (a reading greater than 500 mg/dl) on her sensor so she self-administered insulin to decrease the glucose.The sensor continued to read ¿hi¿ so she again injected insulin, but then she started ¿cramping, was hypoglycemic¿ and then had a seizure.Paramedics were called and customer was transported to a hospital where she was diagnosed with hypoglycemia and admitted.Customer could not recall the specific treatment provided at the hospital.There was no report of death or permanent injury associated with this event.
 
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Brand Name
FREESTYLE LIBRE
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
devin dirstine
1360 south loop road
alameda, CA 94502-7001
5108644391
MDR Report Key7967563
MDR Text Key123797527
Report Number2954323-2018-07727
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 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71702-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2018
Date Manufacturer Received10/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2017
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) Hospitalization; Required Intervention;
Patient Weight52
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