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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 Fever (1858); Discomfort (2330); Shaking/Tremors (2515); Convulsion/Seizure (4406)
Event Date 09/26/2023
Event Type  Injury  
Event Description
A replace sensor error message was reported with the abbott diabetes care (adc) device and customer was unable to obtain readings.Customer is hospitalized for unrelated issues not related to the adc device.As a result, customer experienced "malaise, tremors, fever and convulsion" and was unable to self-treat, requiring healthcare professional administration of unspecified infusion intravenously for treatment.There was no report of death or permanent impairment associated with this event.
 
Event Description
A replace sensor error message was reported with the abbott diabetes care (adc) device and customer was unable to obtain readings.Customer is hospitalized for unrelated issues not related to the adc device.As a result, customer experienced "malaise, tremors, fever and convulsion" and was unable to self-treat, requiring healthcare professional administration of unspecified infusion intravenously for treatment.There was no report of death or permanent impairment associated with this event.
 
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.This also serves as a correction report.
 
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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 Key17878736
MDR Text Key325015435
Report Number2954323-2023-44293
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeFR
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 11/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2023
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? No
Date Manufacturer Received10/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
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