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 Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer experienced bleeding after inserting the abbott diabetes care (adc) sensor.The customer was unable to self-treat required unspecified cream, gauze and a tape from the third-party for treatment.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
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.Sensor (b)(6) has been returned and investigated.Visual inspection performed on the returned sensor patch and no issue was observed.Sensor plug was properly seated.Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.It was unable to perform further investigation due to no product returned.Therefore, issue will be closed to no product returned.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
The customer experienced bleeding after inserting the abbott diabetes care (adc) sensor.The customer was unable to self-treat required unspecified cream, gauze and a tape from the third-party for treatment.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.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.

• 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: 25094556
• Report Number: 2954323-2026-66473
• Device Sequence Number: 9990261
• Product Code: SAF
• UDI-Device Identifier: 00357599848002
• UDI-Public: (01)00357599848002(17)2026-08-31(10)KTP014168(91)77263-01
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/08/2026

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 Expiration Date: 08/31/2026
• Device Model Number: 77263-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2025
• 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: Other
• Patient Sex: Unknown