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 Difficult to Insert (1316)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
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.The date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.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 customer reported the adc freestyle libre 2 sensor did not apply.As a result, the customer reported receiving unspecified third-party medical treatment from someone other than themselves, however, no further information was provided.There was no report of death or permanent injury.
 
Manufacturer Narrative
No product has been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specifications.Dhrs (device history review) for the libre sensor kit were reviewed and the dhrs showed the 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.Per call review with customer, this issue has been determined to be non-reportable.There is no indication that the adc device caused or contributed to a medical event; therefore, adc considers this issue closed.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.This supplement report is to provide additional information that abbott diabetes care became aware of on 12 aug 2021.The following sections have been updated from the previous report, per the additional information: b2 - outcomes attributed to ae.B5 - describe event or problem.H6 - health effect - clinical code and health effect - impact code h10 - addtl mfg narrative.
 
Event Description
A customer reported the adc freestyle libre 2 sensor did not apply.As a result, the customer reported receiving unspecified third-party medical treatment from someone other than themselves, however, no further information was provided.There was no report of death or permanent injury.On (b)(6) 2021, abbott diabetes care (adc) became aware that customer's complaint had been documented incorrectly.Upon review of call with customer, it was determined that customer did not require third-party intervention for the reported sensor application issue.Therefore, based on this new information, abbott diabetes care considers this issue to be non-reportable and closed.
 
Manufacturer Narrative
No product has been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specifications.Dhrs (device history review) for the libre sensor kit were reviewed and the dhrs showed the 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.Section h4 mfg date has been updated based on the extended investigation.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported the adc freestyle libre 2 sensor did not apply.As a result, the customer reported receiving unspecified third-party medical treatment from someone other than themselves, however, no further information was provided.There was no report of death or permanent injury.
 
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 Key12301612
MDR Text Key265832164
Report Number2954323-2021-79632
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 08/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date07/31/2022
Device Model Number71992-01
Was Device Available for Evaluation? No
Date Manufacturer Received08/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-