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

Model Number N/A

Device Problems Failure to Prime (1492); Sticking (1597)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms).Hypoglycemia second time in 2 weeks [hypoglycaemia].Novopen echo is not priming and the piston rod is not coming out [device malfunction].The patient's blood sugar level got to 3.3 and went to 8 and then went down to 3 again [blood glucose fluctuation].Case description: this serious spontaneous case from (b)(6) was reported by a pharmacist as "hypoglycemia second time in 2 weeks", "novopen echo is not priming and the piston rod is not coming out" and "the patient's blood sugar level got to 3.3 and went to 8 and then went down to 3 again" all beginning on an unknown date, and concerned a (b)(6) (age at the time of reporting) male patient who used novopen echo (insulin delivery device) from an unknown date due to type 1 diabetes.The patient's height, weight and body mass index was not reported.Medical history included type 1 diabetes mellitus (duration not reported).Concomitant medications included novorapid penfill (fast acting insulin aspart) and levemir penfill (insulin detemir).Treatment included - glucagen (glucagon).On an unknown date, the patient was hospitalized due to a hypoglycaemia.It was reported that this was the second time in 2 weeks, the patient experienced hypoglycaemia.The patient was also experiencing sickness and diarrhoea.The patient's blood sugar level got to 3.3 and went to 8 and then went down to 3 again (units not reported).Glucagen injection was administered as treatment.On an unknown date, the patient had returned a novopen echo to the pharmacy as it was not priming and the piston rod was not coming out.Action taken to novopen echo was not reported.The overall outcome for the events was unknown.No further information is available at the time of reporting.

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) case description: investigation result: novopen echo; batch: unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission the case has been updated with the following: investigation result updated for novopen echo; manufacturer's comments added.Relevant fields and narrative updated accordingly.Final manufacturer comment: on 22-jul-2015: as novopen echo has not been returned to novonordisk a/s for investigation and only very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in argus case (b)(4).Evaluation summary novopen echo - batch unknown.No investigation was possible, because neither sample nor batch number was available.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hileroed, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S; krogshoejvej 55; bagsvaerd, 2880 ; DA 2880
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536
• MDR Report Key: 4895779
• MDR Text Key: 6536342
• Report Number: 9681821-2015-00021
• 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,foreign,health professi
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• 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: NOT PROVIDED
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2015
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 8 YR