MAUDE Adverse Event Report: Abbott Diabetes Care Inc Lingo Glucose System; N/A

Model Number	77263-01
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A low reading issue with the abbott diabetes care (adc) device was reported.The customer received an unspecified lower scan result on the adc device compared to an unspecified reading obtained on an unknown device.It is unknown whether the customer noted a trend arrow on the device.The customer experienced symptoms such as "feeling tired" and was able to self-treat with foods.Subsequently, the customer was seen at the hospital and further reported receiving third-party treatment from a healthcare professional (hcp) however, details of the treatment for the diagnosis of hyperglycemia were not provided.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The product has been requested back for investigation and the customer agreed to return the device; however, at this time product has not yet been received.An investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the product were reviewed and the dhrs showed the product passed all tests prior to release.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.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.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: Lingo Glucose System
• Common Device Name: N/A
• Manufacturer (Section D): Abbott Diabetes Care Inc; 1360 south loop road; alameda CA 94502 -700
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda, CA 94502--700 ; +1(415)720-5405
• MDR Report Key: 50347141
• Report Number: 2954323-2026-237354
• Device Sequence Number: 16016436
• Product Code: SAF
• UDI-Device Identifier: 00357599848002
• UDI-Public: (01)00357599848002(17)2027-04-30(10)KTP015683(91)77263-01
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 08/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 77263-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown