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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); Weakness (2145); Shaking/Tremors (2515)
Event Date 11/26/2020
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 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.
 
Event Description
A customer reported signal loss while wearing the adc freestyle libre 2 sensor.On (b)(6) 2020, as a result of the loss of signal, there was no glucose alarm alert, the customer experienced 'weak joints," tremors, and was unable to treat themselves.Hcp contact was made and he was given an iv and an injection of jubin (40g) with glucose solution for hypoglycemia.There was no report of death or permanent injury associated with this event.
 
Event Description
A customer reported signal loss while wearing the adc freestyle libre 2 sensor.On (b)(6) 2020, as a result of the loss of signal, there was no glucose alarm alert, the customer experienced 'weak joints," tremors, and was unable to treat themselves.Hcp contact was made and he was given an iv and an injection of jubin (40g) with glucose solution for hypoglycemia.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Sensor 3mh003hc3ar was returned and investigated.The sensor plug was properly seated and no physical damage is observed on the returned sensor patch.Extracted data from the returned sensor using approved software.The sensor found to be in state 5 (indicating normal termination).No failure modes were observed on the sensor plug assembly upon visual inspection.The sensor was activated with a retained reader and the bluetooth connection was successful.A linearity test was performed while the reader was wrapped in aluminum foil (to simulate signal loss), signal loss message was observed.Since the sensor and reader communicated successfully and a signal loss message was observed after simulating a signal loss, the combination of returned sensor and retained reader was found to be functioning properly; therefore this complaint is not confirmed.No malfunction or product deficiency was identified.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 Key10970968
MDR Text Key220402422
Report Number2954323-2020-12881
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 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/31/2022
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2021
Date Manufacturer Received05/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age46 YR
Patient Weight90
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