MAUDE Adverse Event Report: UNOMEDICAL A/S MINMED QUICK SET; UNO INSET II 46/6 SC1 PINK MIMX

Model Number	MMT-921A
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in australia.It was reported that the patient faced adhesive events with 5 infusion sets as the adhesive does not stick well and comes off and does not last the 3 days that it should.The site was reported to be stomach and buttocks.The reporter does not know/are unsure of the cause of the product not adhering.No further information available.
Additional Manufacturer Narrative
Initial and final mdr 1885811 - mdr 3003442380-2024-07942 - device 5 of 5.(b)(6).

• Brand Name: MINMED QUICK SET
• Common Device Name: UNO INSET II 46/6 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: 19526817
• Report Number: 3003442380-2024-07942
• Device Sequence Number: 15347217
• Product Code: FPA
• UDI-Device Identifier: 05705244019911
• UDI-Public: 05705244019911
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160648
• 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): 06/13/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/01/2026
• Device Model Number: MMT-921A
• Device Lot Number: 6001342
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2023
• 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