MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN; INSULIN DELIVERY DEVICE

Catalog Number 185230

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hypoglycemia (1912); Nausea (1970); Overdose (1988); Pneumothorax (2012); Urinary Frequency (2275); Anxiety (2328); Malaise (2359); Coma (2417); Polydipsia (2604)

Event Date 09/27/2013

Event Type  Injury  

Event Description

Found collapsed on the floor at home in a hypoglycaemic state [hypoglycaemia], excessive thirst [thirst], collapsed middle lobe of right lung [pneumothorax], suffered two more hypoglycaemic episodes and went into a coma [hypoglycaemia], increased amount and frequency of urination [urine output increased], increased amount and frequency of urination [pollakiuria], suffered two more hypoglycaemic episodes and went into a coma [hypoglycaemic coma], tests suggested that her insulin dose (via novopen) was incorrect [incorrect dose administered by device], deep and lasting anxiety [anxiety].Case description: does the incident represent a serious public health threat: no.This spontaneous case reported by a consumer from the (b)(6) concerns an (b)(6) female patient, who was treated with novomix 30 penfill (insulin aspart) therapy, and used novopen (insulin delivery device), experienced "found collapsed on the floor at home in a hypoglycaemic state" beginning on (b)(6) 2013 and "collapsed middle lobe of the right lung", "suffered two more hypoglycaemic episodes and went into a coma", "deep and lasting anxiety", "excessive thirst", "increased amount and frequency of urination" and "tests suggested that her insulin dose (via novopen) was incorrect" beginning on unknown date.Furthermore, the patient administered the novomix 30 penfill via a novopen.Patient height: (b)(6).Medical history includes type 2 diabetes mellitus (duration unknown), unspecified senile macular degeneration, primary hyperparathyroidism, thyroid disorder, oesophagitis, low tension glaucoma, open-angle glaucoma - borderlne, bowen's disease, lumbar spinal stenosis, abnormal weight loss, monoclonal gammopathy, sub retinal neovascularisation of macula, closed fracture distal radius, intra-articular, other type, excision of dupuytren's contracture of palm.The patient had reportedly been taking novomix penfill and novopen (unspecified) from an unspecified date for unknown indication.On an unspecified date, the patient started feeling unwell at home which lasted for 3 days with symptoms of increased frequency of urination, excessive thirst, nausea and tiredness.On (b)(6) 2013, the patient was found collapsed on the floor at home in a hypoglycaemic state.The patient was immediately taken by emergency ambulance to the hospital.While in hospital, the patient suffered two more hypoglycaemic episodes and went into coma.The patient showed all the classic symptoms of coma, including increased amount and frequency of urination, excessive thirst, nausea, tiredness, palpitations, sweating, pallor, numbness, headaches, irritability, fatigue, slurred speech and "pins and needles" sensations.Furthermore, the patient also had a collapsed middle lobe of the right lung.Test suggested that the dose of novomix 30 delivered by a novopen was incorrect.At the hospital the dose of insulin was reduced and the patient received unspecified medical treatment for the anxiety.On (b)(6) 2013, the patient was discharged from the hospital.The patient was presented with weight loss and back pain.Proximal myopathy was also noted on admission.Fount to anaemic also.Patient had numerous investigations.Bloods showed high esr (erythrocyte sedimentation rate).Computed tomography of chest/ abdomen/ pelvis showed right middle lobe collapse and abnormal rectal thickening.Bronchoscopy was performed due to acute right middle lobe collapse which was resulted in normal values.Inflexible sigmoidoscopy performed- one plop identified.Rectal biopsy taken resulted in rectal abnormality.Mobilisation and analgesia advised in light of mri scan.Skeletal survey advised also and the patient was switched to folic acid.Patient reviewed in clinic on (b)(6) 2013: the patient stated that she felt fit as a fiddle and her bronchoscopy was completely normal.Chest x-ray on that day doesn't show any change from previous inpatient film.Patient reviewed in clinic on (b)(6) 2013: the patient was presented with some weight loss and some back pain.However, there was no evidence of end organ damage with normal renal function, a normal skeletal survey and an mri (magnetic resonance imaging) that did show some possible marrow abnormality but only degenerative changes.The patient was diagnosed as very well for her age.Does have slight back pain but that does not have worsened over the past 6 months and well be attributed to her known degenerative disease.The patient appeared to be eating more and putting weight back on.Patient reviewed in clinic on (b)(6) 2013: the bronchoscopy was entirely normal and her weight had also increased.Patient continued under haematology review.On (b)(6) 2014, it was reported by the patient's son that the pen the patient was using was the original grey pen (use ongoing without any issues) with the company logo on it and the patient was not able to say which type of novopen it was.Action taken to novomix 30 penfill was reported as dose decreased.The overall outcome of the events was reported as recovered.Analysis result: name: novomix 30 penfill 3 ml.Batch number: cs6d422.The product was not returned for examination.A batch trend report has been created.Nothing abnormal was found.This product is part of the recall initiated by novo nordisk at the end of (b)(6) 2013 where certain batches of novomix30 were recalled in 13 european countries.On (b)(6) 2014, follow up received, suspect device novopen added.Company comment: novomix 30 is used for treatment of diabetes mellitus in adults.As novomix 30 contains rapid action and intermediate-acting insulin aspart, the mechanism of acting is to lower blood glucose levels.Dosing is individual and determined in accordance with the needs of the patient.Therefore, novo nordisk evaluates the causality between the events due to low blood sugar and the suspected products as possible.However, the events "increased amount and frequency of urination" and "excessive thirst" are not typical symptoms of hypoglycaemic episodes.Reporter comment: doctor did not think that there was significant pathology in this case.

• Brand Name: NOVOPEN
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd ; DA
• Manufacturer (Section G): NOVO NORDISK A/S - MEDICAL SYSTEMS; brennum park; hilleroed 3400 ; DA 3400
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 6099875831
• MDR Report Key: 3621493
• MDR Text Key: 4133077
• Report Number: 9681821-2014-00002
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K861686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Type of Report: Initial
• Report Date: 11/04/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 185230
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2014
• 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: TX DATE: (B)(6) 2010 TO (B)(6) 2013; 40 U, QD (18 AM+ 22 PM); TRAVOPROST (TRAVOPROST),; NOVOMIX 30 PENFILL REGIMEN #2,; TX DATE: (B)(6) 2008 - ONGOING; NOVOFINE 8MM (30G) (NEEDLE) N/A
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 84 YR
• Patient Weight: 68