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

Model Number	77263-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Infection (4544); Skin Inflammation/ Irritation (4545)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
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 reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the product.The device history records (dhrs) for the product were reviewed and the dhrs showed the product passed all tests prior to release.Dose audit reports were reviewed and demonstrated the continued effectiveness of the established sterilization process for the products.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.The most probable root causes associated with this incident are the adhesive, including the adhesive irritating the user¿s skin, or misuse, including improper site selection and repeatedly using the same application site to place the sensor.These conditions are mitigated through the product labelling.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.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Abbott diabetes care (adc) received a complaint via email.A customer reported that while using the lingo glucose biosensor, they experienced severe irritation and was unable to self-treat.The customer sought medical attention and was prescribed mupirocin cream.The customer mentioned that they applied the cream from october 2 to (b)(6) 2025, and noted an improvement in the crusty bumps after three days of use.There was no report of death or permanent impairment associated with this event.
Event or Problem Description
Abbott diabetes care (adc) received a complaint via email.A customer reported that while using the lingo glucose biosensor, they experienced severe irritation and was unable to self-treat.The customer sought medical attention and was prescribed mupirocin cream.The customer mentioned that they applied the cream from october 2 to october 4, 2025, and noted an improvement in the crusty bumps after three days of use.There was no report of death or permanent impairment 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, no product has been received at this time despite follow up attempts by adc.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.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the lingo glucose biosensor.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor products.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.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 sensor kit was reviewed and the dhrs showed the lingo glucose biosensor and sensor kit met specifications prior to release to distribution.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.This serves as a correction report.Section h11 (additional mfr narrative) was incorrectly documented in initial report.The correction has been made in this report.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 7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda, CA 94502-7001 ; 4157205405
• MDR Report Key: 23478652
• Report Number: 2954323-2025-43683
• Device Sequence Number: 18698923
• Product Code: SAF
• UDI-Device Identifier: 00357599848002
• UDI-Public: (01)00357599848002(17)2025-12-31(10)KTP011915(91)77263-01
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/31/2025

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 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: 10/10/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown