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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 72114-01
Device Problem High Readings (2459)
Patient Problems Hypoglycemia (1912); Chills (2191); Loss of consciousness (2418)
Event Date 04/08/2022
Event Type  Injury  
Event Description
A complaint was received regarding unspecified higher glucose scan values while wearing the adc device.As a result, the customer had symptom of hypoglycemia described as chills and had a loss of consciousness.The customer was provided an unspecified emergency injection by a non-healthcare professional for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.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.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.
 
Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.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.Shelf life studies and dose audits were performed during product development and on market performance continues to be monitored for this product.All monitoring processes meet adc requirements.A tracking and trending data is not currently captured because it is newly released product and does not have sufficient data to be able to establish a baseline complaint rate at this time.The baselines will be established within 12 months from release if a stable complaint rate has been reached.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 complaint was received regarding unspecified higher glucose scan values while wearing the adc device.As a result, the customer had symptom of hypoglycemia described as chills and had a loss of consciousness.The customer was provided an unspecified emergency injection by a non-healthcare professional for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
 
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Brand Name
FREESTYLE LIBRE 3
Type of Device
CONTINUOUS 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 Key14136786
MDR Text Key289452599
Report Number2954323-2022-12618
Device Sequence Number1
Product Code QLG
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 06/23/2022
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 Model Number72114-01
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/11/2022
Initial Date FDA Received04/18/2022
Supplement Dates Manufacturer Received06/08/2022
Supplement Dates FDA Received06/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/11/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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