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 High Readings (2459)
Patient Problems Loss of consciousness (2418); Sweating (2444); Shaking/Tremors (2515); Confusion/ Disorientation (2553)
Event Date 10/20/2020
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.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A high readings issue was reported with the use of the adc freestyle libre 2 sensor.A customer reported receiving sensor readings of 14 mmol/l, 22.3 mmol/l, 12.2 mmol/l, 17.4 mmol/l, and 17.8 mmol/l as compared to built-in meter readings of 2.8 mmol/l, 4.8 mmol/l, 5.8 mmol/l, 8.2 mmol/l, and 8.6 mmol/l.The customer experienced symptoms described as ¿sweating, outbursts, trembling, confusing talk, and a loss of consciousness¿ and was unable to self-treat.The results of the reading comparison, when plotted on a parkes error grid, fell into the "d" zone showing the difference in values to be clinically significant.The customer further reported being diagnosed with hypoglycemia but no further details were provided.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor 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.
 
Event Description
A high readings issue was reported with the use of the adc freestyle libre 2 sensor.A customer reported receiving sensor readings of 14 mmol/l, 22.3 mmol/l, 12.2 mmol/l, 17.4 mmol/l, and 17.8 mmol/l as compared to built-in meter readings of 2.8 mmol/l, 4.8 mmol/l, 5.8 mmol/l, 8.2 mmol/l, and 8.6 mmol/l.The customer experienced symptoms described as ¿sweating, outbursts, trembling, confusing talk, and a loss of consciousness¿ and was unable to self-treat.The results of the reading comparison, when plotted on a parkes error grid, fell into the "d" zone showing the difference in values to be clinically significant.The customer further reported being diagnosed with hypoglycemia but no further details were provided.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 is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Inspected the plug assembly, no issues were observed.The current was applied to the sensor to perform linearity testing while in the test fixture.All results were within specification.Issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A high readings issue was reported with the use of the adc freestyle libre 2 sensor.A customer reported receiving sensor readings of 14 mmol/l, 22.3 mmol/l, 12.2 mmol/l, 17.4 mmol/l, and 17.8 mmol/l as compared to built-in meter readings of 2.8 mmol/l, 4.8 mmol/l, 5.8 mmol/l, 8.2 mmol/l, and 8.6 mmol/l.The customer experienced symptoms described as ¿sweating, outbursts, trembling, confusing talk, and a loss of consciousness¿ and was unable to self-treat.The results of the reading comparison, when plotted on a parkes error grid, fell into the "d" zone showing the difference in values to be clinically significant.The customer further reported being diagnosed with hypoglycemia but no further details were provided.There was no report of death or permanent impairment associated with this event.
 
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 Key10755053
MDR Text Key213658277
Report Number2954323-2020-09030
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 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/30/2021
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2020
Initial Date Manufacturer Received 10/20/2020
Initial Date FDA Received10/29/2020
Supplement Dates Manufacturer Received11/11/2020
02/17/2021
Supplement Dates FDA Received11/13/2020
02/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age70 YR
-
-