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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); Vertigo (2134); Sweating (2444)
Event Date 09/22/2018
Event Type  Injury  
Manufacturer Narrative
The product has not been requested back for an investigation.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
Customer reported he received a "hi¿ message (a reading greater than 500 mg/dl) from his adc freestyle libre sensor.The customer stated that he experienced symptoms of hypoglycemia, including ¿increased sweating, dizziness and loss of balance¿.Customer self-treated with a glucagon injection.No additional treatment was reported.No third party medical intervention was required.Customer declined to provide any additional information.
 
Manufacturer Narrative
Additional information: (device mfg date) has been updated.Visual inspection has been performed on the returned sensor patch and no issues were observed.The sensor plug was not correctly seated during visual inspection.The complaint is not confirmed to a use issue.No product deficiency was identified.
 
Event Description
Customer reported he received a "hi¿ message (a reading greater than 500 mg/dl) from his adc freestyle libre sensor.The customer stated that he experienced symptoms of hypoglycemia, including ¿increased sweating, dizziness and loss of balance¿.Customer self-treated with a glucagon injection.No additional treatment was reported.No third party medical intervention was required.Customer declined to provide any additional information.
 
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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 Key7985215
MDR Text Key124356399
Report Number2954323-2018-07834
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 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2018
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 Manufacturer10/23/2018
Date Manufacturer Received11/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2018
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 Weight81
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