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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 Detachment of Device or Device Component (2907)
Patient Problems Fainting (1847); Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 07/20/2020
Event Type  Injury  
Manufacturer Narrative
At this time product has not yet been returned.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor kit was reviewed and the dhrs showed the libre sensor kit passed all tests prior to release.The date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer called to report a delivery issue and noted that due to not receiving the product, resulted in a medical event.The customer initially reported on (b)(6) 2020, that the adc freestyle libre sensor detached on the same day of application.On (b)(6) 2020, the customer reported that due to a delivery issue involving the replacement product, she was unable to check her glucose levels and experienced fainting and loss of consciousness.The customer was treated with a glucose injection by paramedics.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
tara williamson
1360 south loop road
alameda, CA 94502-7001
5108644472
MDR Report Key10340709
MDR Text Key200873058
Report Number2954323-2020-05094
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
Report Date 07/29/2020
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 Date05/31/2021
Device Model Number71940-01
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/20/2020
Initial Date FDA Received07/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2020
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;
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