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

Catalog Number 04626478001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hyperglycemia (1905)

Event Date 09/29/2020

Event Type  Injury  

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.Product no longer available for return.

Event Description

It was reported that an occlusion occurred in the infusion set resulting in elevated blood glucose levels.The patient was admitted into the hospital due to hyperglycemia with blood glucose results of 25.0 mmol/l and "hi" mmol/l.There was also pus at the infusion site after the 4th day of using the infusion set.The patient cannot affirm that the cannula caused the pus.The type of treatment provided to the patient in the hospital was not provided.The patient was in the hospital for two days.

• Brand Name: ACCU-CHEK FLEXLINK INFUSION SET
• Type of Device: SUBCUTANEOUS INFUSION SET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10669872
• MDR Text Key: 211018210
• Report Number: 3011393376-2020-03694
• 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: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2021
• Device Catalogue Number: 04626478001
• Device Lot Number: 5296615
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN.; UNKNOWN INSULIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 23 YR
• Patient Weight: 51