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 Power Problem (3010)
Patient Problem Hypoglycemia (1912)
Event Date 04/20/2021
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 caller reported on behalf of a ((b)(6)-year-old child) customer whose adc freestyle libre 2 reader would not turn on when the button was pressed.The customer was not able to monitor their blood glucose experienced a symptom of sleepiness and required third-party sugar water as treatment.No further information was reported.There was no report of death or permanent injury 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 (device history review) for the libre reader was reviewed and the dhrs showed the libre reader 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 caller reported on behalf of a (5-year-old child) customer whose adc freestyle libre 2 reader would not turn on when the button was pressed.The customer was not able to monitor their blood glucose experienced a symptom of sleepiness and required third-party sugar water as treatment.No further information was reported.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
The reported reader (mbga153-j0240) was returned and investigated with retained strips.A visual inspection was performed on the reader and no issues were observed.The reader does not turn on with start button.The reader turns on with usb (universal serial bus) charging cable and strip insertion.Connected the reader to the computer and masterm software was not able to recognize the reader.The reader was sent for further investigation.The reader was de-cased and no issues were observed upon visual inspection.The battery was measured.The reader was then placed into the reader pcba (printed circuit board of assembly) test fixture and pressure was applied to the cpu (central processing unit.) observed the reader turned on.Therefore, it is not confirmed.
 
Event Description
A caller reported on behalf of a (5-year-old child) customer whose adc freestyle libre 2 reader would not turn on when the button was pressed.The customer was not able to monitor their blood glucose experienced a symptom of sleepiness and required third-party sugar water as treatment.No further information was reported.There was no report of death or permanent injury 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 Key11838897
MDR Text Key251096043
Report Number2954323-2021-69474
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 09/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71953-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2021
Date Manufacturer Received08/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age5 YR
Patient Weight21
-
-