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

Lot Number ASKU

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

Patient Problem Hyperglycemia (1905)

Event Date 06/01/2018

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.

Event Description

It was reported that the self-adhesive of the infusion sets were not sticking well enough, which resulted in leaks.The caller alleged that this was ongoing issue and has occurred with different boxes of infusion sets.On (b)(6) 2018 the patient discovered that her infusion set was not sticking to her skin and there was a leak.The patient experienced elevated blood glucose symptoms and her husband transported her to the hospital.At the hospital the patient received a blood glucose result of 36.4 mmol/l.The hospital treated the patient with a "drip" and potassium.The patient was hospitalized for 2 days.The lot numbers were not provided.The infusion sets were discarded; therefore, no product could be 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: 7646372
• MDR Text Key: 112610182
• Report Number: 3011393376-2018-02718
• 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
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2018
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR