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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 Hyperglycemia (1905); Malaise (2359); Convulsion/Seizure (4406)
Event Date 05/22/2022
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
An alarm issue was reported with the adc device.Customer reported a signal loss which prevented the sounding of high and low glucose alarms.As a result, customer was unaware of changes in glucose levels and reportedly experienced a seizure while sleeping.Upon waking, customer experienced red eyes and "feeling bad" and self-treated with insulin (dose/type unspecified).No additional treatment was reported.There was no report of death or permanent injury 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 as of this report.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.Attempted to activate high/low glucose alarms with an iphone xr using a good known libre 2 sensor.The iphone xr successfully receive high/low glucose alarms.No issue were identified with the librelink app.If the product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
An alarm issue was reported with the adc device.Customer reported a signal loss which prevented the sounding of high and low glucose alarms.As a result, customer was unaware of changes in glucose levels and reportedly experienced a seizure while sleeping.Upon waking, customer experienced red eyes and "feeling bad" and self-treated with insulin (dose/type unspecified).No additional treatment was reported.There was no report of death or permanent injury associated with this event.
 
Event Description
An alarm issue was reported with the adc device.Customer reported a signal loss which prevented the sounding of high and low glucose alarms.As a result, customer was unaware of changes in glucose levels and reportedly experienced a seizure while sleeping.Upon waking, customer experienced red eyes and "feeling bad" and self-treated with insulin (dose/type unspecified).No additional 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.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.Set the low and high glucose thresholds in the reader¿s alarm settings.Activated sensor with a known good reader and performed linearity test.Low and high glucose results were successfully activated.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
 
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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 Key14603462
MDR Text Key293364344
Report Number2954323-2022-18187
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeDA
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,Followup
Report Date 11/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date03/31/2023
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received11/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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