MAUDE Adverse Event Report: UNOMEDICAL UM-D ACCU-CHEK TENDERLINK; AC TENDERLINK I 13/60 10PCS

Model Number	04541600001
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 germany.It was reported that the patient experienced infusion set cannula was leaking at the connection which occurred on an unknown date.It was also reported that the patient was feeling well.No further information was available.
Additional Manufacturer Narrative
Correction: this mdr is being submitted to correct the manufacturing date under h4.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 complaint (b)(4) has been evaluated.The batch 6005422 in question was manufactured at the reynosa site.Investigation process of the complaint was carried out in accordance with work instruction (wi) guidance for visual testing for complaints area version 2 and wi guidance for functional testing for complaints area version 1 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.Test results: visual test according to wi version 2 on reference samples, 10 samples out 10 samples passed the test.Functional test air flow according to wi version 1 on reference samples, 10 samples out 10 samples passed the test.Functional test leak under water according to wi version 1 on reference samples, 10 samples out 10 samples passed the test.Device history record (dhr) review: packaging: the lot 6005422 was packing according to the wi version 16 manufactured in the line m10, on 04/feb/2024, with a total of (b)(4) units.Cannula comfort assembly: the lot 4a06355 was assembled according to wi version 14 on-line inspection for cannula comfort line on 29 jan 2024, 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, no maintenance events were recorded.Trending: a query was run in database on 07/mar/2025 against malfunction code leakage from infusion site (cannula base part/cannula) (specific cause not identified) and lot 6005422 and no other complaint has been registered in database for the same lot 6005422 and malfunction code.Conclusion summary of the related event: as a result of the following: harm no reportable, no defect on tests for returned/retention samples, no non-conformance (nc) raised during production, only one complaint received on the lot in question and malfunction code, no further actions are required.Therefore, this issue will be monitored through the post market vigilance 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 13/60 10PCS
• Manufacturer (Section D): UNOMEDICAL UM-D; ave. fomento industrial l9 m3; parque industrial del norte; reynosa, tamps, 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 21582477
• Report Number: 3003442380-2025-03473
• Device Sequence Number: 15757421
• Product Code: FPA
• UDI-Device Identifier: 05705244008502
• UDI-Public: 05705244008502
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143446
• 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): 03/11/2025

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 Model Number: 04541600001
• Device Lot Number: 6005422
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 51 YR
• Patient Sex: Male