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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM

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ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 72081-01
Device Problem Device Alarm System (1012)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 03/16/2022
Event Type  Injury  
Manufacturer Narrative
At this time product has not yet been returned. An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification. The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release. If the product is returned, a physical investigation will be performed and a follow-up report submitted. This report is being filed on an international product, model number 72114-01 which has a similar product distributed in the u. S. , model number 71992-01 all pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A signal loss issue was reported with the adc device. A customer reported encountering a loss of signal after starting the sensor and as a result, the customer became hypoglycemic and experienced a loss of consciousness. The customer was unable to self-treat and received a sugar solution as treatment from the wife. No further information was reported. There was no report of death or permanent injury associated with this event.
 
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Brand NameFREESTYLE LIBRE 3
Type of DeviceCONTINUOUS GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE LTD
range road
witney 12345 -700
UK 12345-7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key13902327
MDR Text Key288014644
Report Number2954323-2022-09949
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2022
Device Model Number72081-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received09/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/25/2022 Patient Sequence Number: 1
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