MAUDE Adverse Event Report: ACCU-CHEK ® SPIRIT TENDERLINK INFUSION SET; SUBCUTANEOUS INFUSION SET

Lot Number 5259356

Device Problem Fluid/Blood Leak (1250)

Patient Problem Injection Site Reaction (4562)

Event Date 07/06/2021

Event Type  malfunction  

Manufacturer Narrative

The event occurred outside of the united states.While this product is not sold in the united states, it is like or similar to a product marketed in the united states.

Event Description

It was reported that the infusion set was leaking at the headset.The user also reported that he has some inflammation at the insertion site.

• Brand Name: ACCU-CHEK ® SPIRIT TENDERLINK INFUSION SET
• Type of Device: SUBCUTANEOUS INFUSION SET
• MDR Report Key: 12199806
• MDR Text Key: 262556173
• Report Number: 3011393376-2021-02191
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2023
• Device Lot Number: 5259356
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN; UNKNOWN INSULIN
• Patient Age: 24 YR