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

Model Number	04530039001
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the insertion device ejected the infusion set unintentionally.The customer further alleged the device is not blocked but it is released with difficulty.

• Brand Name: ACCU-CHEK LINKASSIST
• Common Device Name: SPRING LOADED INSERTION DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11567950
• Report Number: 3011393376-2021-00959
• Device Sequence Number: 4352538
• Product Code: KZH
• UDI-Device Identifier: 04015630048601
• UDI-Public: 04015630048601
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 04530039001
• Device Catalogue Number: 04530039001
• Device Lot Number: 151509
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 06/25/2021
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 18