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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAYS; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAYS; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71940-01
Device Problem High Readings (2459)
Patient Problems Hypoglycemia (1912); Vertigo (2134)
Event Date 03/13/2019
Event Type  Injury  
Manufacturer Narrative
The reported product is not expected to be returned as reporter indicated the device was discarded.A follow-up report will be filed if product is returned or 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
Customer reported receiving unspecified high readings on the adc freestyle libre sensor.Customer further reported experiencing symptoms described as "irregular strong hearth rhythm" and vertigo and being hospitalized.Customer's glucose was monitored every 30 minutes and he was diagnosed with hypoglycemia and treated with intravenous glucose.It is unknown when customer was discharged there was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
No product has been returned and a valid serial number has not been provided.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for libre sensors was reviewed and showed no anomalies or non-conformance's that could have lead to the complaint.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.If the product is returned, the case will be re-opened and a physical investigation will be performed.
 
Event Description
Customer reported receiving unspecified high readings on the adc freestyle libre sensor.Customer further reported experiencing symptoms described as "irregular strong hearth rhythm" and vertigo and being hospitalized.Customer's glucose was monitored every 30 minutes and he was diagnosed with hypoglycemia and treated with intravenous glucose.It is unknown when customer was discharged there was no report of death or permanent injury associated with this event.
 
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Brand Name
FREESTYLE LIBRE 14 DAYS
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
MDR Report Key8538319
MDR Text Key142732656
Report Number2954323-2019-03243
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 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2019
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 Received11/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age66 YR
Patient Weight82
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