MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK LINKASSIST PLUS INSERTION DEVICE; SPRING LOADED INSERTION DEVICE

Catalog Number 05511097001

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hyperglycemia (1905)

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 cannula was not inserted properly and the self-adhesive of the infusion set was wet with insulin.

• Brand Name: ACCU-CHEK LINKASSIST PLUS INSERTION DEVICE
• Type of Device: SPRING LOADED INSERTION DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10612681
• MDR Text Key: 209356998
• Report Number: 3011393376-2020-03554
• Device Sequence Number: 1
• Product Code: KZH
• 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: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 05511097001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Date Manufacturer Received: 11/02/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN; UNKNOWN INSULIN
• Patient Age: 66 YR