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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 Insufficient Information (3190)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Diaphoresis (2452)
Event Date 03/19/2023
Event Type  Injury  
Event Description
Customer reported an unknown unspecified issue while using an adc device and additionally reported they experienced a medical event.As a result, the customer experienced sweating, "deliration" and a loss of consciousness and could not self-treat.Emergency services were called, upon arrival, firefighter got a glucose test result of 22 mg/dl on the hcp meter and treated the customer with glucagon "30%".Customer was taken to the hospital where they received an infusion of glucagon "30%" by a healthcare professional for a diagnosis of hypoglycemia.No further details were provided.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and 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.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.The sensor plug is properly seated, and no physical damage was observed.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.Sim vivo testing (simulation of the electrical signal produced by the sensor tail) was performed and all results were within specification.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported an unknown unspecified issue while using an adc device and additionally reported they experienced a medical event.As a result, the customer experienced sweating, "deliration" and a loss of consciousness and could not self-treat.Emergency services were called, upon arrival, firefighter got a glucose test result of 22 mg/dl on the hcp meter and treated the customer with glucagon "30%".Customer was taken to the hospital where they received an infusion of glucagon "30%" by a healthcare professional for a diagnosis of hypoglycemia.No further details were provided.There was no report of death or permanent impairment associated with this event.
 
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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 Key16672642
MDR Text Key312586925
Report Number2954323-2023-13352
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 07/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date02/29/2024
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received06/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/23/2022
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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