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

Catalog Number 06541801001

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354)

Patient Problem Hyperglycemia (1905)

Event Date 06/03/2018

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.This case, with patient identifier (b)(4), is related to case with patient identifier (b)(4).

Event Description

It was reported that the self-adhesive of the infusion set was not sticking well enough, which resulted in a leak.The patient experienced elevated blood glucose levels.No adverse event was reported.The infusion set was requested to be returned for product evaluation.

• 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
• Manufacturer (Section G): GERRESHEIMER REGENSBURG GMBH; hirtenstrasse 50; na; pfreimd 92536 ; GM 92536
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 7600887
• MDR Text Key: 111033544
• Report Number: 3011393376-2018-02510
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/30/2019
• Device Catalogue Number: 06541801001
• Device Lot Number: 1200761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOVORAPID INSULIN
• Patient Age: 27 YR