MAUDE Adverse Event Report: MIO¿ ADVANCE; UNO MIO ADV. GREY 60/6 SC1 10-PK INT

Lot Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4) event occurred in slovakia on(b)(6) 2024, it was reported that the patient faced an insulin flow block alarm.No further information was available.

• Brand Name: MIO¿ ADVANCE
• Type of Device: UNO MIO ADV. GREY 60/6 SC1 10-PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre ; 0045481670
• MDR Report Key: 19171583
• MDR Text Key: 341665702
• Report Number: 8021545-2024-00138
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018877
• UDI-Public: 05705244018877
• Combination Product (y/n): N
• PMA/PMN Number: K173879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/10/2024
• Patient Sequence Number: 1