MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK INSIGHT FLEX; SUBCUTANEOUS INFUSION SET

Lot Number 1306895

Device Problem Fluid/Blood Leak (1250)

Patient Problem Injection Site Reaction (4562)

Event Date 04/06/2021

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 customer reported that the adhesive plaster was wet and that the skin under the infusion set was red and swollen.

• Brand Name: ACCU-CHEK INSIGHT FLEX
• Type of Device: SUBCUTANEOUS INFUSION SET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11632512
• MDR Text Key: 244365916
• Report Number: 3011393376-2021-01141
• 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: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/16/2022
• Device Lot Number: 1306895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Date Manufacturer Received: 05/21/2021
• Patient Sequence Number: 1
• Treatment: NOVORAPID INSULIN; NOVORAPID INSULIN
• Patient Age: 22 YR
• Patient Weight: 96