MAUDE Adverse Event Report: Abbott Diabetes Care Inc FreeStyle Freedom Lite; System, Test, Blood Glucose, Over The Counter

Model Number	70914-70
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The meter was returned and investigated.Visual inspection was performed on returned meter, and no issues were observed.The indicator lights did not flash.The meter did not power on with button depression and strip insertion.Meter communication was initiated using usb cable plugged to the meter usb port and a computer usb port and connected to approved software.Meter display was not on and communication was not successful.The returned meter was further de-cased and investigated.Internal visual inspection was performed and liquid contamination was observed on the pcba (printed circuit board assembly).Therefore, issue is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
The reporter contacted abbott diabetes care, alleging the meter will not turn on.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no report of death, serious injury, or mistreatment associated with this event.

• Brand Name: FreeStyle Freedom Lite
• Common Device Name: System, Test, Blood Glucose, Over The Counter
• Manufacturer (Section D): Abbott Diabetes Care Inc; 1360 south loop road; alameda CA 94502 -700
• Manufacturer Contact: melissa pieplow ; 1360 south loop road; alameda, CA 94502--700 ; +1(510)384-5975
• MDR Report Key: 50516750
• Report Number: 2954323-2026-309393
• Device Sequence Number: 15833300
• Product Code: NBW
• UDI-Device Identifier: 00699073000026
• UDI-Public: (01)00699073000026(10)02W306D(17)180630
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 70914-70
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown