MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK 3.15 ML INSULIN CARTRIDGE; INSULIN INFUSION PUMP ACCESSORY

Lot Number ASKU

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2020

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 insulin cartridge leaked insulin into the cartridge compartment of the infusion device.

• Brand Name: ACCU-CHEK 3.15 ML INSULIN CARTRIDGE
• Type of Device: INSULIN INFUSION PUMP ACCESSORY
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11423473
• MDR Text Key: 235000092
• Report Number: 3011393376-2021-00745
• Device Sequence Number: 1
• Product Code: LZG
• 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: 04/13/2021

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 Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 03/30/2021
• Supplement Dates FDA Received: 04/13/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN; UNKNOWN INSULIN