MAUDE Adverse Event Report: MIO; UNO INSET II 46/6 SC1 PINK MIMX

Lot Number	UNKNOWN
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 4 of 4.
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in australia.It was reported that the patient had been experiencing consecutive high blood glucose (bg) levels since last night and this issue continues to persist.The patient had changed the set for their insulin pump four times since last night.Additionally, the pump had triggered an insulin flow blockage.The patient's bg level at the time of the incident was measured at 22 mmol/l.To address the high bg levels, the patient has been manually injecting insulin.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 46/6 SC1 PINK MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19348358
• Report Number: 3003442380-2024-02531
• Device Sequence Number: 15240795
• Product Code: FPA
• UDI-Device Identifier: 05705244019911
• UDI-Public: 5705244019911
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2024

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
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 05/18/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown