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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 Fall (1848); Loss of consciousness (2418)
Event Date 02/04/2022
Event Type  Injury  
Manufacturer Narrative
The reported product is not expected to be returned as reporter indicated the device was discarded.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A high readings issue was reported with the adc device.A customer reported receiving unspecified high sensor scans and based on the sensor result, the customer self-treated with 8 units of insulin.Consequently, the customer fell (broken noise, knocked his head and shoulders) and lost consciousness.The ambulance took the customer to a hospital where the customer¿s head was scanned, an x-ray on the shoulder, checked oxygen, heart via cardiogram, and an echocardiogram was performed the next morning.No further information was reported.There was no report of death or permanent injury 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
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key13803143
MDR Text Key287385847
Report Number2954323-2022-08804
Device Sequence Number1
Product Code PZE
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P160030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date09/30/2022
Device Model Number71940-01
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/07/2022
Initial Date FDA Received03/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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