MAUDE Adverse Event Report: Unomedical Devices S.A de C.V Comfort; Set, Administration, Intravascular

Model Number	1002828
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Premature Separation (4045)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient faced 2 infusion sets falling off during use, leading to high blood glucose above 500 mg/dl, which was treated with a correction bolus via pump on (b)(6)2026.
Additional Manufacturer Narrative
Mdr (b)(4) / initial 1 of 2 e1: name: tandem country: united states of america street: 11045 roselle street city: san diego state: california zip code: 92121 based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 8021545 manufacturing site: 3003442380.

• Brand Name: Comfort
• Common Device Name: Set, Administration, Intravascular
• Manufacturer (Section D): Unomedical Devices S.A de C.V; ave.fomento industrial l9 m3; parque industrial del norte; reynosa,tamps. 88736 ; MX 88736
• Manufacturer (Section G): Unomedical Devices S.A de C.V; ave.fomento industrial l9 m3; parque industrial del norte; reynosa,tamps. 88736 ; MX 88736
• Manufacturer Contact: armando cuello ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; +1(603)247-0255
• MDR Report Key: 50931848
• Report Number: 3003442380-2026-010971
• Device Sequence Number: 15850322
• Product Code: FPA
• UDI-Device Identifier: 05705244018723
• UDI-Public: 05705244018723
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K162812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: 1002828
• Device Lot Number: 6012043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2025
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male