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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 Device Alarm System (1012); No Audible Alarm (1019)
Patient Problems Hypoglycemia (1912); Diaphoresis (2452); Shaking/Tremors (2515)
Event Date 02/04/2023
Event Type  Injury  
Event Description
An alarm issue was reported with the abbott diabetes care (adc) application in use with an android operating system.The low and high glucose alarms did not sound, and customer was not alerted of changes in glucose level.As a result, the customer experienced sweating, tremor and palpitations and was unable to self-treat, requiring treatment by glucagon injection (dose unknown) provided by non-healthcare professional (non-hcp).There was no report of death or permanent injury 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.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 sensors 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.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the sensor patch.The sensor was found to be in state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The reported sensor was activated with a retained reader and linearity testing was performed, all results were within specification.Low glucose alarm was successfully activated.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
An alarm issue was reported with the abbott diabetes care (adc) application in use with an android operating system.The low and high glucose alarms did not sound, and customer was not alerted of changes in glucose level.As a result, the customer experienced sweating, tremor and palpitations and was unable to self-treat, requiring treatment by glucagon injection (dose unknown) provided by non-healthcare professional (non-hcp).There was no report of death or permanent injury 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 Key16401837
MDR Text Key309876359
Report Number2954323-2023-07306
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeSP
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 03/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date12/31/2023
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received03/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2022
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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