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

Model Number N/A

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Nocturnal hypoglycaemia [hypoglycaemia].Mixed up her two blue novopen echo pens in the night [wrong device used].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "nocturnal hypoglycaemia(hypoglycaemia night)" with an unspecified onset date, "mixed up her two blue novopen echo pens in the night (wrong device used)" with an unspecified onset date, and concerned a (b)(6) year old female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", the patient's height, weight and body mass index were not reported.Current condition: type 1 diabetes mellitus (duration not reported).On an unspecified date, reported as sometime ago, the patient mixed up her two blue novopen echo pens in the night and had nocturnal hypoglycaemia so that emergency doctor had to come.Batch number of novopen echo has been requested.The outcome for the event "nocturnal hypoglycaemia(hypoglycaemia night)" was not reported.The outcome for the event "mixed up her two blue novopen echo pens in the night (wrong device used)" was not reported.In order to protect the safety of patient it will, in rare cases, be required to disassemble the medical device immediately in a way where it is not subsequently possible to reassemble it (e.G.Destructive testing or altering of the medical device).The disassembled medical device will be stored with the same retention period as other complaint samples.Preliminary manufacturer's comment: on 20-nov-2020: the suspected device (novopen echo) has not been returned to novo nordisk for evaluation.No conclusion has been reached.Elderly age of the patient ((b)(6) years) is a significant risk factor for device confusion at night, which could have lead to hypoglycaemia.

Event Description

Case description: investigation result.Product: novopen echo.Batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Product: fiasp penfill.Batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Product: levemir penfill.Batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the following has been updated in the case, investigation result updated, annex b, c, d and g codes updated.Catalog# updated, manufacturer comment updated, narrative updated accordingly.Final manufacturer's comment: 07-jan-2021: the suspected device (novopen echo) has not been returned to novo nordisk for evaluation.The reported batch number is not valid.Batch trend analysis not performed.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse events.However, patient is a trained user, used dialing click to estimate the dose of the insulin.It was reported that novopen echo blue was defective, 5 years old and it fell apart during the injection.Elderly age of the patient (71 years) is a significant risk factor for device confusion at night, patient administered accidental overdose of bolus insulin which could have led to hypoglycaemic unconsciousness.H3: continued: evaluation summary: investigation result: product: novopen echo.Batch number: unknown.No investigation was possible, because neither sample nor batch number was available.

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) nocturnal hypoglycaemia and unconscious [hypoglycaemic unconsciousness] mixed up her two blue novopen echo pens in the night [wrong device used] novopen echo blue was defective, it fell apart during the injection [device defective] accidentally injected a large amount of bolus insulin in the evening [accidental overdose].Case description: this serious spontaneous case from germany was reported by a consumer as "nocturnal hypoglycaemia and unconscious(hypoglycaemic unconsciousness)" with an unspecified onset date, "mixed up her two blue novopen echo pens in the night(wrong device used)" with an unspecified onset date, "novopen echo blue was defective, it fell apart during the injection(device defective)" with an unspecified onset date, "accidentally injected a large amount of bolus insulin in the evening(accidental overdose)" with an unspecified onset date, and concerned a 71-year-old female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", fiasp (insulin aspart) solution for injection, 100 u/ml (dose, frequency & route used - 25 - 30 iu daily, subcutaneous) (therapy dates - ongoing) from unknown start date and ongoing for "type 1 diabetes mellitus" and levemir penfill (insulin detemir) solution for injection,.0024 mol/l (dose, frequency & route used - 18 - 21 iu daily, subcutaneous) from unknown start date for "type 1 diabetes mellitus".Patient's height: 162 cm.Patient's weight: 78 kg.Patient's bmi: 29.721.Dosage regimens: novopen echo: fiasp: 25 - 30 iu daily, levemir penfill: 18 - 21 iu daily.Current condition: type 1 diabetes mellitus ((b)(6)1994).Concomitant products included - simvabeta(simvastatin) and ibersartan (non-codable).Treatment included - glucose.Patient became unconscious at night with emergency medical attention because i accidentally injected a large amount of bolus insulin in the evening.Patient was treated with a high glucose dose by the emergency doctor.After this incident patient immediately received a red novopen.It was reported that novopen echo blue was defective, it fell apart during the injection.The patient used the dialing clicks to estimate the dose of the insulin.Batch numbers: novopen echo: asku.Fiasp: asku.Levemir penfill: asku.Action taken to novopen echo was not reported.Action taken to fiasp was reported as no change.Action taken to levemir penfill was not reported.On 06-nov-2020 the outcome for the event "nocturnal hypoglycaemia and unconscious(hypoglycaemic unconsciousness)" was recovered.The outcome for the event "novopen echo blue was defective, it fell apart during the injection(device defective)" was not reported.The outcome for the event "accidentally injected a large amount of bolus insulin in the evening(accidental overdose)" was not reported.Since last submission, the following has been updated in the case, new events 'novopen echo blue was defective, it fell apart during the injection' and 'accidentally injected a large amount of bolus insulin in the evening' added.Event verbatim updated as 'nocturnal hypoglycaemia and unconscious' along with medical coding.References included: reference type: e2b company number, reference id#: (b)(4).Reference type: mw 3500a mfr.Rpt.#, reference id#: (b)(4).Reference notes: medwatch 3500a mfr.Report number reference type: e2b report duplicate, reference id#: (b)(4), reference notes: bfarm (bundesinstitut fur arzneimittel und medizinprodukte), deu.Preliminary manufacturer's comment: 30-nov-2020: the suspected device (novopen echo) has not been returned to novo nordisk for evaluation.No conclusion has been reached.Patient is a trained user, however used dialing click to estimate the dose of the insulin.It was reported that novopen echo blue was defective, 5 years old and it fell apart during the injection.Elderly age of the patient (71 years) is a significant risk factor for device confusion at night, patient administered accidental overdose of bolus insulin which could have led to hypoglycaemic unconsciousness.

Event Description

Case description: this serious spontaneous case from germany was reported by a consumer as "nocturnal hypoglycaemia and unconscious(hypoglycaemic unconsciousness)" with an unspecified onset date, "mixed up her two blue novopen echo pens in the night(wrong device used)" with an unspecified onset date, "novopen echo blue was defective, it fell apart during the injection(device defective)" with an unspecified onset date, "accidentally injected a large amount of bolus insulin in the evening(accidental overdose)" with an unspecified onset date, and concerned a 71-year-old female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", fiasp (insulin aspart) from unknown start date and ongoing for "type 1 diabetes mellitus" and levemir penfill (insulin detemir) from unknown start date for "type 1 diabetes mellitus".Action taken to novopen echo was not reported.Investigation result: name: novopen echo 1.Batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Name: novopen echo 2.Batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the following has been updated in the case, -2nd novopen echo blue pen added as suspect and investigation result updated for same -narrative updated accordingly.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 10914492
• MDR Text Key: 219955810
• Report Number: 9681821-2020-00059
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/17/2020

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 Model Number: N/A
• Device Catalogue Number: 185458
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 11/27/2020
• Supplement Dates Manufacturer Received: 11/24/2020; 01/04/2021; 11/17/2020
• Supplement Dates FDA Received: 12/09/2020; 01/13/2021; 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIMVABETA (SIMVASTATIN) TABLET --/--/2011 TO UNK.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 78