MAUDE Adverse Event Report: UNOMEDICAL A/S ACCU-CHEK® TENDERLINK; AC TENDERLINK I 17/110 10PCS.

Model Number	04541626001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in austria it was reported that patient faced infusion set leakage event.Leakage was between connection to the adapter and cartridge.No further information available.
Additional Manufacturer Narrative
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 complaint (b)(4) has been evaluated.The batch 5383896 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 connection of hub to the reservoir.Complaint investigations.Photo/sample was not provided.In order to test the product, the reference samples from the lot has been requested.The following test was performed: visual test according to with wi version 7 on reference samples, 10 samples out 10 samples passed the test.Functional test 1 according to with document version 10 on reference samples, 10 samples out 10 samples passed the test.Functional test 2 according to with document version 44 on reference samples, 10 samples out 10 samples passed the test.A batch record review was conducted resulting in the following: the lot 5383896 was manufactured according to the document version 11 on the packing process in the line multivac 10, on 06/may/2022, with a total of (b)(4) units.Review of the device history record (dhr) showed that all relevant tests required during the related process had been fulfilled and met the requirements.Trending: a query was run in database on 04/jul/2025 against malfunction code leakage from connection of hub to the reservoir and lot 5383896 and no other complaint has been registered in database for the same lot and malfunction code.Conclusion summary of the related event: as a result of the following: no defect on tests for reference samples, no harm, no non-conformance (nc) raised during production, no complaint received on the lot in question and malfunction code.No further actions are required.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® TENDERLINK
• Common Device Name: AC TENDERLINK I 17/110 10PCS.
• 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: 20755948
• Report Number: 3003442380-2024-32705
• Device Sequence Number: 21167417
• Product Code: FPA
• UDI-Device Identifier: 05705244009233
• UDI-Public: 05705244009233
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• 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): 07/04/2025

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: 04/04/2025
• Device Model Number: 04541626001
• Device Lot Number: 5383896
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2022
• 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 Sex: Male