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

Model Number N/A

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

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Severe hypoglycaemic episode [hypoglycaemia].Mix-up of both pens [wrong device used].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "severe hypoglycaemic episode" and "mix-up of both pens" both with an unspecified onset date, and concerned a (b)(6) patient who was treated with co-suspect novorapid penfill (fast acting insulin aspart) from unknown start date and two suspect novopens both from unknown date all for type 1 diabetes mellitus.Non-novo nordisk suspected product included lantus (insulin glargine) used from unknown start date due to type 1 diabetes mellitus.(b)(6).Medical history included type 1 diabetes mellitus and hypertension diagnosed on (b)(6) 2007.Concomitant product included ramilich (ramipril).On an unspecified date 12 weeks ago, the patient had a severe hypoglycaemic episode during the use of novorapid penfill and novopens.The patient's blood glucose decreased from 370 to 31 within a few hours (units not reported).It was reported that it could not be handled at home; therefore, the patient went to hospital (hospitalisation dates are not reported).The physicians thought that the patient had mixed-up the novopens and therefore the severe hypoglycaemic episode occurred.Following hospitalisation, training was conducted for the patient.No sample was available for investigation.Action taken to novorapid penfill, lantus and the 2 novopens was not reported.The overall outcome was not reported.Investigation results: novorapid® penfill® 100 e/ml injektionslosung in einer patrone - batch unknown no investigation was possible, because neither sample nor batch number was available.Novopen 1: no investigation was possible, because neither sample nor batch number was available.Novopen 2: no investigation was possible, because neither sample nor batch number was available.Manufacturer's final comment: (b)(6) 2015: hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement.The mix-up of the pens might be the likely cause for the hypoglycaemic episode in this case.As both pens have not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of suspected pens is available, it is not possible to identify a clear root-cause of the mix-up and thus find similar incidents to the one reported in argus case (b)(4).Evaluation summary no investigation was possible, because neither sample nor batch number was available.

• 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; hilleroed, 3400 ; DA 3400
• Manufacturer Contact: novoprod novo nordisk inc. ; p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 5301652
• MDR Text Key: 33597634
• Report Number: 9681821-2015-00043
• 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: consumer,foreign
• Type of Report: Initial
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 185230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2015
• 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: RAMILICH (RAMIPRIL)
• Patient Outcome(s): Hospitalization
• Patient Age: 40 YR
• Patient Weight: 78