MAUDE Adverse Event Report: UNOMEDICAL A/S ACCU-CHEK® TENDERLINK; AC TENDERLINK CANNULA 13 10PCS

Model Number	05015260001
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).On 27-june-2024, it was reported that patient faced a ketoacidos episode due to adhesive plaster of tenderlink cannula.No further information was available.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
The following tests were completed for 10 reference samples of lot 5376472: 1.Visual inspection as per (b)(4) packaging criteria (criterios de empaque) flex set/sample book of packing area flex set version 12.10 samples visually inspected and no damages or bent.

• Brand Name: ACCU-CHEK® TENDERLINK
• Common Device Name: AC TENDERLINK CANNULA 13 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: 19700471
• Report Number: 3003442380-2024-13208
• Device Sequence Number: 3702634
• Product Code: FPA
• UDI-Device Identifier: 05705244005099
• UDI-Public: 05705244005099
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2024

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: 05015260001
• Device Lot Number: 5376472
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2022
• 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: 74 YR
• Patient Sex: Male