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 71953-01
Device Problem Product Quality Problem (1506)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 01/03/2022
Event Type  malfunction  
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.The dhrs (device history review) for the fs libre reader were reviewed and the dhrs showed the fs libre reader passed all tests prior to release.Dhr's verified that the correct cable and adapter were part of the kit pack.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
Customer reports that their freestyle libre 2 reader, emitted a spark right after it was plugged in.Customer further reported an electric shock from their libre 2 reader.There was no report of death, serious injury, or mistreatment associated with this event.
 
Event Description
Customer reports that their freestyle libre 2 reader, emitted a spark right after it was plugged in.Customer further reported an electric shock from their libre 2 reader.There was no report of death, serious injury, or mistreatment associated with this event.
 
Manufacturer Narrative
Reader (b)(6) was returned and investigated.Visual inspection was performed and cracked case of the reader was observed.No evidence of sparks were observed.Therefore, this issue is not confirmed to use due to cracked reader case.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
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key13358150
MDR Text Key286640445
Report Number2954323-2022-02886
Device Sequence Number1
Product Code QLG
UDI-Device Identifier00357599803001
UDI-Public00357599803001
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 06/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number71953-01
Device Catalogue Number71953
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received05/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-