MAUDE Adverse Event Report: UNOMEDICAL A/S ACCU-CHEK ULTRFLEX INFUSION SET; UNO ULTRAFLEX I 60/8 DIDU

Model Number	04626583001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial and final mdr (b)(4).Device 1 of 2.E1: patient city: (b)(6).Patient country: brazil.
Event or Problem Description
Reference number (b)(4).Event occurred in brazil.It was reported that the patient faced two infusion set cannula were leaking events on (b)(6) 2024.The events occurred immediately after insertion.The insertion site was at the abdomen, legs and flanks.No further information was available.
Additional Manufacturer Narrative
Supplemental report 01 - mdr 2065106 - mdr 3003442380-2024-32994 additional information - this mdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions h11: investigation summary the information in this (b)(4) has been evaluated.The batch 5402098 in question was manufactured at the reynosa site.Investigation process of the complaint was carried out in accordance with work instruction (wi) guideline for test of ref.Samples version 11 for the code leakage from infusion site (cannula base part/cannula) (specific cause not identified).Complaint investigations.Photo/sample was not provided.In order to test the product, the reference samples from the lot have been requested.A complaint investigation has been initiated.The reference samples for the lot 5402098 have been tested in database record 2065106 on 20-nov-2024.The following test was performed: visual test according to with wi version 38 on reference samples, 10 samples out 10 samples passed the test.Functional test 1 according to with wi version 10 on reference samples, 10 samples out 10 samples passed the test.Functional test 2 according to with wi version 7 on reference samples, 10 samples out 10 samples passed the test.Device history record (dhr) review: packaging a batch record review was conducted resulting in the following: the lot 5402098 was manufactured according to the document version 42 on the packing process in the line multivac 07, on 26/nov/2022, with a total of (b)(4) units.Assembly cannula: the lot 5406040 was manufactured according to the document version 34 in the line 02, on 24/nov/2022, with a total of (b)(4) units.Review of the dhr showed that all relevant tests required during the related processes had been fulfilled and met the requirements.No deviation were identified related to the malfunction reported, no maintenance events were recorded.Trending: a query was run in database on 24-jun-2025 against malfunction code leakage from infusion site (specific cause not identified) and lot 5402098 and another one complaint has been registered in database for the same lot and malfunction code.Conclusion summary of complaint investigation: as a result of the following: no defect on tests for reference samples, no non-conformance (nc) raised during production related to complaint code, another 1 complaint received on the lot in question and malfunction code.This complaint will not require further root cause investigation nor capa plan.Therefore, this issue will be monitored through the post market surveillance activities.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: ACCU-CHEK ULTRFLEX INFUSION SET
• Common Device Name: UNO ULTRAFLEX I 60/8 DIDU
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, ca 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 20804377
• Report Number: 3003442380-2024-32994
• Device Sequence Number: 21289721
• Product Code: FPA
• UDI-Device Identifier: 04015630049929
• UDI-Public: 04015630049929
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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 Expiration Date: 10/25/2025
• Device Model Number: 04626583001
• Device Lot Number: 5402098
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 11/28/2024
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2022
• 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 Age: 44 YR
• Patient Sex: Female