MAUDE Adverse Event Report: UNOMEDICAL A/S MINIMED QUICK SET; UNO INSET II 60/6 SC1 PINK MCAN

Model Number	MMT-923A600
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	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in canada.It was reported that the patient faced an adhesive event with an infusion set as the infusion set and the sensor fell off after being used for 1 day.Patient confirmed to not perspire heavily and was unsure of the cause of the product not adhering.No further information available.

• Brand Name: MINIMED QUICK SET
• Common Device Name: UNO INSET II 60/6 SC1 PINK MCAN
• 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: 19526833
• Report Number: 3003442380-2024-07953
• Device Sequence Number: 7483411
• Product Code: FPA
• UDI-Device Identifier: 05705244020245
• UDI-Public: 05705244020245
• 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-923A600
• Device Lot Number: 6001488
• 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: 05/23/2023
• 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