MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LITE; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	70805-70
Medical Device Problem Codes	Failure to Power Up (1476); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
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.
Additional Manufacturer Narrative
The product has been requested back for an investigation and the customer agreed to return the device; however, at this time product has not yet been received.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.An extended investigation has been conducted, which involved a manufacturing review (including 5 years of device history records (dhrs)), previous complaint and corrective and preventive action (capa) investigations conducted for blank screen issues, process failure mode effects analyses (pfmeas), design controls, and design failure mode effects analyses (dfmeas), risk management reports, risk evaluations, and label copy.The investigation did not identify any indication that the product did not meet specification.If product is returned, a physical investigation will be performed per adc's established processes and procedures and a report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.
Additional Manufacturer Narrative
The returned meter was investigated with retained test strips and a known-good retained battery.A visual inspection of the meter was performed, and no new issues were identified.The meter did not power on via button press or test strip insertion.The returned meter was then de-cased for further investigation.A visual inspection of the de-cased meter revealed no observable issues, and no faulty components were identified.Additional inspection using a digital microscope also showed no anomalies.The device was then brought to the bench for functional testing.Since batteries were not returned, a known-good battery was used.The device failed to power on using button depression, test strip insertion, or charging cable insertion.Wires were found soldered to the voltage traces, and an external power supply was connected to these wires to power the device.A power consumption test was performed, and the results were outside the specified range.Mix-match testing was conducted by swapping the central processing unit (cpu) with a known-good device.After the swap, the device powered on normally using all activation methods (button, test strip, and charging cable).A subsequent power consumption test produced results within the specified range.Based on the swap testing, the cpu was identified as the faulty component and confirmed as the root cause of the customer complaint.With the known-good cpu, the device passed all functional tests.The issue is confirmed.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 LITE
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda 94502 7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda 94502-7001 ; 4157205405
• MDR Report Key: 22563327
• Report Number: 2954323-2025-28323
• Device Sequence Number: 15789734
• Product Code: NBW
• UDI-Device Identifier: 00093815708292
• UDI-Public: (01)00093815708292(10)02C336D
• 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): 04/02/2026

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: 70805-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2022
• 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 Age: 79 YR
• Patient Sex: Unknown
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White