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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 Alarm System (1012)
Patient Problems Hypoglycemia (1912); Muscle Spasm(s) (1966); Seizures (2063); Loss of consciousness (2418)
Event Date 10/23/2020
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 review) 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
Customer reported experiencing signal loss while wearing a freestyle libre 2 sensor and the low glucose alarm not being triggered, resulting in him experiencing spasms, "foaming at mouth", seizure and a loss of consciousness.Customer was incapable of self-treating and was administered a glucagon injection and oral glucose by a third-party.No further treatment was reported.There was no report of death or permanent injury associated with this event.
 
Event Description
Customer reported experiencing signal loss while wearing a freestyle libre 2 sensor and the low glucose alarm not being triggered, resulting in him experiencing spasms, "foaming at mouth", seizure and a loss of consciousness.Customer was incapable of self-treating and was administered a glucagon injection and oral glucose by a third-party.No further treatment was reported.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 was properly seated, and no physical damage was observed on the sensor patch.Upon visual inspection of the sensor assembly, a broken snap was observed.Extracted data from the returned sensor using approved software.The sensor was found to be in state 5 (indicating normal termination).The reported sensor was activated with a retained reader and linearity testing was performed, all results were within specification.Both high and low glucose alarms were successfully activated.No malfunction or product deficiency was identified.Upon visual investigation of the sensor plug, it was noted that a broken snap was observed.This issue was noted during the investigation, and was not part of the customers' original complaint, nor did it impact the glucose alarms.All pertinent information available to abbott diabetes care has been submitted.Additional information- section g1: (contact office first name, contact office last name, contact office phone number, and contact office email) have been updated.
 
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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
MDR Report Key10750009
MDR Text Key213635398
Report Number2954323-2020-08910
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date07/31/2021
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2020
Date Manufacturer Received03/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age15 YR
Patient Weight67
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