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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 Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Fall (1848); Hypoglycemia (1912); Convulsion/Seizure (4406)
Event Date 11/28/2021
Event Type  Injury  
Event Description
An error message issue was reported with the freestyle libre sensor.The customer obtained a "replace sensor" message upon scanning on the seventh day of wear and as a result, was unable to obtain glucose scans.The customer experienced seizure and subsequently fell down.The customer's daughter called an ambulance, but customer reported being to self-treat with glucose aide and ambulance was "called off".No additional treatment was reported.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The device manufacturing 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.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.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
An error message issue was reported with the freestyle libre sensor.The customer obtained a "replace sensor" message upon scanning on the seventh day of wear and as a result, was unable to obtain glucose scans.The customer experienced seizure and subsequently fell down.The customer's daughter called an ambulance, but customer reported being to self-treat with glucoseaide and ambulance was "called off".No additional treatment 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 Key13020342
MDR Text Key282379918
Report Number2954323-2021-95812
Device Sequence Number1
Product Code PZE
Combination Product (y/n)N
Reporter Country CodeUK
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,Followup
Report Date 12/28/2021
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 Date11/30/2022
Device Model Number71940-01
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/07/2021
Initial Date FDA Received12/16/2021
Supplement Dates Manufacturer Received12/27/2021
Supplement Dates FDA Received12/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2021
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 SexFemale
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