MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. INSET; UNO INSET I 80/6 GREY BETA 10PK BETA

Model Number	FG000016-05
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that the patient re-use of single use device on (b)(6) 2025.The blood glucose level was 295 mg/dl no further information available.
Additional Manufacturer Narrative
Since no lot number is available, a detailed investigation, tests or reference samples or batch review cannot be concluded.Therefore, this complaint will be closed, this issue will be monitored through pms product trends and malfunction.If any trends picked up, this will flag on the trips and alerts according to the omqr procedure.

• Brand Name: INSET
• Common Device Name: UNO INSET I 80/6 GREY BETA 10PK BETA
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave, fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p., mexico 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 23520990
• Report Number: 3003442380-2025-16177
• Device Sequence Number: 9742065
• Product Code: FPA
• UDI-Device Identifier: 05705244026254
• UDI-Public: 05705244026254
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K032854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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 Model Number: FG000016-05
• Device Lot Number: UNKNWON
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown