MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC LINGO GLUCOSE SYSTEM; N/A

Model Number	77263-01
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reports electric shock on the fifth day of wear, while wearing an abbott diabetes care device.There was no report of fire, smoke, or explosion.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
The reported product has been returned and is currenlty undergoing investigation.A follow-up report will be submitted upon completion of investigation activities or if additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Additional Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.Visual inspection performed on the returned sensor and sensor plug and the sensor plug is fully seated.Customer stated that the sensor had worn for 4 days without issue, then randomly on 5th day forward to feel a electric shock.No evidence of burn marks was observed.The returned sensor was further investigated and de-cased.Performed an internal visual inspection on the sensor¿s pcba (printed circuit board assembly); no issues were observed.An extended investigation was performed.The puck was received by the hardware product quality engineering (hpqe) team.A visual inspection was performed using a digital microscope (eq5324) on the returned puck.No signs of damage were observed during the inspection.An smu (source meter unit) test was performed to check the functionality of the returned puck and check the accuracy of the puck's readings.The returned puck had an electrical current measured to be within specification indicating no accuracy issues were present in the puck.Additionally, a poise voltage test was performed and results that were within specification were observed, indicating no issues with electrical signal lines integral to the glucose reading process of the returned puck.The poise voltage test was performed.A temperature test was performed, while the room temperature was within specification indicating that the puck's thermistor was fully functional.A current consumption test was performed using a keithley source meter.The returned puck had an off-current measurement of 48na and an on-current measurements of 30ua, which is within specification.The results of the current consumption test show that the returned sensor is not drawing excess current in an activated or inactivated state; therefore, the observation of electric shocks is not confirmed.The returned sensor passed all testing, and no evidence of a product malfunction was observed during the investigation this issue is not confirmed.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.Dhrs (device history review) for the libre sensor and sensor kit was reviewed and the dhrs showed the libre sensor and sensor kit met specifications prior to release to distribution.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A customer reports electric shock on the fifth day of wear, while wearing an abbott diabetes care device.There was no report of fire, smoke, or explosion.There was no report of death, serious injury, or mistreatment associated with this event.

• Brand Name: LINGO GLUCOSE SYSTEM
• Common Device Name: N/A
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda, CA 94502-7001 ; 4157205405
• MDR Report Key: 22916347
• Report Number: 2954323-2025-34458
• Device Sequence Number: 18607970
• Product Code: SAF
• UDI-Device Identifier: 00357599848002
• UDI-Public: (01)00357599848002(17)2026-02-28(10)KTP011912(91)77263-01
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K233655
• 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): 06/11/2026

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 Expiration Date: 02/28/2026
• Device Model Number: 77263-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown