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

Model Number	77263-01
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested back for investigation and the customer agreed to return the device.A follow-up report will be submitted upon completion of investigation activities or if additional information is obtained.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.
Event or Problem Description
A customer reported prior to use they observed their" biosensor damage" with use of the abbott diabetes care (adc) device and was not received in sterile condition.In addition, the customer stated, "there was brown substance on the top." there was no indication that the customer applied the device to their body, and no patient consequences were reported.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
The most probable root causes associated with this failure mode are disconnected, faulty or damaged components 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.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 performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the lingo glucose biosensor and biosensor kit was reviewed and the dhrs showed the lingo glucose biosensor and biosensor kit met specifications prior to release to distribution.The reported product is not expected to be returned as reporter indicated the device was discarded.Therefore, no further investigation is planned.In the event that product is received, 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.
Event or Problem Description
A customer reported prior to use they observed their" biosensor damage" with use of the abbott diabetes care (adc) device and was not received in sterile condition.In addition, the customer stated, "there was brown substance on the top." there was no indication that the customer applied the device to their body, and no patient consequences were reported.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
The most probable root causes associated with this failure mode are disconnected, faulty or damaged components 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.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 performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the lingo glucose biosensor and biosensor kit was reviewed and the dhrs showed the lingo glucose biosensor and biosensor kit met specifications prior to release to distribution.The reported product is not expected to be returned as reporter indicated the device was discarded.Therefore, no further investigation is planned.In the event that product is received, 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.
Event or Problem Description
A customer reported prior to use they observed their" biosensor damage" with use of the abbott diabetes care (adc) device and was not received in sterile condition.In addition, the customer stated, "there was brown substance on the top." there was no indication that the customer applied the device to their body, and no patient consequences were reported.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: 23753915
• Report Number: 2954323-2025-47553
• Device Sequence Number: 14958408
• Product Code: SAF
• UDI-Device Identifier: 00357599848002
• UDI-Public: (01)00357599848002(17)2025-12-31(10)KTP011461(91)77263-01
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 01/14/2026

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: 12/31/2025
• Device Model Number: 77263-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 01/14/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/14/2026; 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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