MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC EXTENDED INFUSION SET; UNO EWIS BLUE 80/9 HCAP 3-PK INT

Model Number	MMT-442AH
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: canada.H11: since no lot number is available, a detailed investigation, tests on reference samples or batch review cannot be conducted.Therefore, this complaint will be closed, this issue will be monitored through pms product trends and malfunction.If any trends picked up, this will flag on the trips and alerts according to the omqr procedure.
Event or Problem Description
Reference number (b)(4).Event occurred in canada.It was reported that the patient faced an event where infusion set pulled out on 06-jul-2024.The blood glucose level was 22.2 mmol/l at the time of event therefore, the patient was treated with bolus correction.No further information was available.

• Brand Name: MEDTRONIC EXTENDED INFUSION SET
• Common Device Name: UNO EWIS BLUE 80/9 HCAP 3-PK INT
• 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: 19921318
• Report Number: 8021545-2024-03055
• Device Sequence Number: 7601912
• Product Code: FPA
• UDI-Device Identifier: 05705244023314
• UDI-Public: 05705244023314
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210544
• 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): 07/07/2024

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-442AH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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