Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71992-01
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Chills (2191); Dizziness (2194); Confusion/ Disorientation (2553)
Event Date 05/11/2021
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
A caregiver reported that prior to receiving the ¿sensor ended¿ message, the customer had received a scan of 55 mg/dl on the adc freestyle libre 2 sensor.It was further reported that the sensor stopped working and the customer experienced symptoms of dizziness, disorientation, accelerated heartbeat, chills, and nervousness.A non-hcp provided the customer with coco-cola as treatment and no further information was reported.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
No product has 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 caregiver reported that prior to receiving the ¿sensor ended¿ message, the customer had received a scan of 55 mg/dl on the adc freestyle libre 2 sensor.It was further reported that the sensor stopped working and the customer experienced symptoms of dizziness, disorientation, accelerated heartbeat, chills, and nervousness.A non-hcp provided the customer with coco-cola as treatment and no further information was reported.There was no report of death or permanent impairment associated with this event.
 
Event Description
A caregiver reported that prior to receiving the ¿sensor ended¿ message, the customer had received a scan of 55 mg/dl on the adc freestyle libre 2 sensor.It was further reported that the sensor stopped working and the customer experienced symptoms of dizziness, disorientation, accelerated heartbeat, chills, and nervousness.A non-hcp provided the customer with coco-cola as treatment and no further information was reported.There was no report of death or permanent impairment 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.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 6 (indicating abnormal termination) with a brownout reset event internally logged (event 21).Inspected the sensor plug assembly and no failure modes were observed.Observed the sensor state 6 occurred after reprogramming and activating the sensor.Observed (event log 11) occur which indicates a temporary drop in the source voltage.The sensor was de-cased, and the battery was replaced.A sim vivo test (simulation of the electrical signal produced by the sensor tail) was performed.All results were within specification.Therefore, this issue is not confirmed.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11858617
MDR Text Key251815348
Report Number2954323-2021-69870
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,Followup
Report Date 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/30/2022
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2021
Date Manufacturer Received08/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight60
-
-