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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71992-01
Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 10/23/2021
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 record) for the libre sensor and libre sensor kit were reviewed, and the dhrs showed the libre sensor and libre sensor kit 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
A customer reported a "replace sensor" message with the freestyle libre 2 sensor.The customer reported the night of (b)(6) 2021, customer had muscle spasms while sleeping and could not be awoken by her husband.Sensor readings were unable to be obtained, but her husband treated her with sugar-water.No further treatment was required.There was no report of death or permanent injury associated with this event.
 
Event Description
A customer reported a "replace sensor" message with the freestyle libre 2 sensor.The customer reported the night of (b)(6) 2021, customer had muscle spasms while sleeping and could not be awoken by her husband.Sensor readings were unable to be obtained, but her husband treated her with sugar-water.No further treatment was required.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Extended investigation has been performed.A visual inspection has been performed and no issue was observed.Extracted data using approved software from the returned puck and observed device is not compatible error message.The sensor is bricked.Issue is unable to test.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported a "replace sensor" message with the freestyle libre 2 sensor.The customer reported the night of (b)(6) 2021, customer had muscle spasms while sleeping and could not be awoken by her husband.Sensor readings were unable to be obtained, but her husband treated her with sugar-water.No further treatment was required.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.The sensor plug is properly seated and no physical damage was observed on the sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.An error has been occurred during reprogramming.This error prevented the returned patch from being reprogrammed and therefore, adc was therefore unable to perform further testing related to the high readings issue reported by the customer.Section h6 (investigation findings) code 4247 (appropriate term/code not available) was selected, as adc was unable to perform further testing on the returned device.All pertinent information available to abbott diabetes care has been submitted.
 
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Brand Name
FREESTYLE LIBRE 2
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 Key12796851
MDR Text Key280679365
Report Number2954323-2021-92242
Device Sequence Number1
Product Code QLG
UDI-Device Identifier00357599800000
UDI-Public00357599800000
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193371
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,Followup
Report Date 03/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date02/28/2022
Device Model Number71992-01
Device Catalogue Number71992
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2021
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2021
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
Patient Weight62 KG
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