MAUDE Adverse Event Report: UNOMEDICAL A/S MINIMEDÂ; UNO INSET II 60/6 SC1 PINK MIMX

Model Number	MMT-923A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Patient country: australia.
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in australia.On (b)(6) 2024, it was reported that the patient faced that the infusion set had occlusion that prevents the flow of insulin, which cause the patient blood glucose elevated to 378 mg/dl.The patient also had symptoms of vomiting nauseous and thirst.No further information available.

• Brand Name: MINIMEDÂ
• Common Device Name: UNO INSET II 60/6 SC1 PINK MIMX
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19772070
• Report Number: 8021545-2024-02190
• Device Sequence Number: 20902631
• Product Code: FPA
• UDI-Device Identifier: 05705244019942
• UDI-Public: 05705244019942
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173879
• 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): 07/16/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-923A
• Device Lot Number: 6003873
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 07/18/2024
• 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