MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN ECHO; INSULIN DELIVERY DEVICE

Catalog Number NOT PROVIDED

Device Problem Failure to Deliver (2338)

Patient Problems Malaise (2359); Diabetic Ketoacidosis (2364)

Event Date 05/11/2014

Event Type  Injury  

Event Description

Failure of device to actually deliver insulin [device failure] admitted with diabetic ketoacidosis (dka) [diabetic ketoacidosis] became very unwell [malaise].Case description: this serious spontaneous case from the (b)(6) ws received via (b)(6) and reported by a general practitioner as "failure of device to actually deliver insulin" with an unspecified onset date, "admitted with diabetic ketoacidosis (dka)" and "became very unwell" both beginning on (b)(6) 2014, and concerned a female patient (age not reported) who was treated with novopen echo (insulin delivery device) subcutaneously as device therapy from (b)(6) 2014 due to "ill-defined disorder" and "type 1 diabetes mellitus", patient's height, weight and bmi were not reported.Medical history includes type 1 diabetes mellitus and ill-defined disorder.Concomitant products included - levemir (insulin determir), novorapid (insulin aspart), pravastatin (pravastatin), amlodipine(amlodipine), fenofibrate (fenofibrate), candesartan (candesartan) and cetirizine (cetirizine).Reporter confirmed that patient still have the pen and would return it for investigation.The outcome for the event "failure of device to actually deliver insulin" was not reported.The outcome for the event "admitted with diabetic ketoacidosis (dka)" and became very unwell" was recovered on (b)(6) 2014.Action taken for reaction : product withdrawn.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed ; DA
• Manufacturer (Section G): NOVO NORDISK A/S; krogshoejvej 55; bagsvaerd 2880 ; DA 2880
• Manufacturer Contact: po box 846; plainsboro, NJ 08536 ; 6099875831
• MDR Report Key: 3964013
• MDR Text Key: 4625094
• Report Number: 9681821-2014-00033
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Type of Report: Initial
• Report Date: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2014
• Initial Date FDA Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NOVORAPID (INSULIN ASPART) SOLUTION OR INJECTION,; FENOFIBRATE (FENOFIBRATE); CETIRIZINE (CETIRIZINE); CANDESARTAN (CANDESARTAN); LEVEMIR (INSULIN DETERMIR) SOLUTION FOR INJECTIN,; PRAVASTATIN (PRAVASTATIN); 100 U/ML; .0024 MOL/L; AMLODIPINE (AMLODIPINE)
• Patient Outcome(s): Life Threatening