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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 Problem Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Cognitive Changes (2551)
Event Date 07/05/2023
Event Type  Injury  
Event Description
An error message was reported with the abbott diabetes care (adc) device.Customer received a "replace sensor" message and was unable to obtain readings.As a result, customer experienced "memory loss" and self-treated with "food" prior to having contact with a healthcare professional (hcp).The hcp provided third-party treatment of intravenous glucose "drops" (type/dose unspecified).There was no report of death or permanent impairment 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.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
An error message was reported with the abbott diabetes care (adc) device.Customer received a "replace sensor" message and was unable to obtain readings.As a result, customer experienced "memory loss" and self-treated with "food" prior to having contact with a healthcare professional (hcp).The hcp provided third-party treatment of intravenous glucose "drops" (type/dose unspecified).There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
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.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.Current was applied to the sensor to perform sim vivo testing (simulation of the electrical signal produced by the sensor tail) and poise voltage testing.All results were within specification.No malfunction or product deficiency was identified.Therefore issue is not confirmed.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 Key17315846
MDR Text Key319011324
Report Number2954323-2023-30150
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeFI
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
Report Date 09/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received08/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2023
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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