MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 5; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Crack (1135); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Hypoglycemia (1912); Vertebral Fracture (4520)

Event Date 01/27/2022

Event Type  Injury  

Event Description

(related symptoms if any separated by commas).Compression fracture (two vertebrae were badly damaged) [spinal compression fracture], very strong hypoglycaemia - patient was unconscious [hypoglycaemic unconsciousness], cartridge can be inserted, but does not hold.Crack in cartridge holder lock [device breakage].Case description: this serious spontaneous case from germany was reported by a consumer as "compression fracture (two vertebrae were badly damaged)(spinal compression fracture)" with an unspecified onset date, "very strong hypoglycaemia - patient was unconscious(hypoglycaemic unconsciousness)" with an unspecified onset date, "cartridge can be inserted, but does not hold.Crack in cartridge holder lock(device cracked)" with an unspecified onset date, and concerned a 59 years old male patient who was treated with novopen 5 (insulin delivery device) from unknown start date for "device therapy".Patient's height, weight, body mass index were not reported.Current condition: type 1 diabetes mellitus.(duration not reported).On an unknown date, during use of novopen 5 the patient experienced a very strong hypoglycemia.During this hypoglycaemia he was unconscious and got a compression fracture.As a result, two vertebrae were badly damaged.Patient still has pain from it.It was reported that the cartridge can be inserted, but does not hold.Novopen 5 has crack in cartridge holder lock.Batch numbers of novopen 5: unavailable.The outcome for the event "compression fracture (two vertebrae were badly damaged)(spinal compression fracture)" was not reported.The outcome for the event "very strong hypoglycaemia - patient was unconscious(hypoglycaemic unconsciousness)" was not reported.The outcome for the event "cartridge can be inserted, but does not hold.Crack in cartridge holder lock(device cracked)" was not reported.Preliminary manufacturer's comment: 14-jun-2022: the suspected device novopen 5 has not been returned to novo nordisk for evaluation.No conclusion is reached.Patient had spinal compression fracture during hypoglycaemic unconsciousness."this report is for a foreign device that is assessed as "similar" to us marketed novopen echo".Reporter comment: non valid batch number provided - fvg8659.

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) thoracic vertebrae 3 compression fracture(two vertebrae were badly damaged) [spinal compression fracture].Very strong hypoglycaemia - patient was unconscious [hypoglycaemic unconsciousness] cartridge can be inserted, but does not hold.Crack in cartridge holder lock [device breakage].Case description: this serious spontaneous case from germany was reported by a consumer as "thoracic vertebrae 3 compression fracture(two vertebrae were badly damaged)(spinal compression fracture)" beginning on 27-jan-2022, "very strong hypoglycaemia - patient was unconscious(hypoglycaemic unconsciousness)" beginning on (b)(6) 2022, "cartridge can be inserted, but does not hold.Crack in cartridge holder lock(device cracked)" beginning on (b)(6) 2022, and concerned a 59 years old male patient who was treated with novopen 5 (insulin delivery device) from unknown start date for "device therapy", , protaphane (insulin human) suspension for injection (dose, frequency & route used - unk) from unknown start date for "drug use for unknown indication", , actrapid (insulin human) solution for injection (dose, frequency & route used - unk) from unknown start date for "drug use for unknown indication", patient's height: 170 cm.Patient's weight: 88 kg.Patient's bmi: 30.449827.Dosage regimens of protaphane and actrapid were not reported.Current condition: type 1 diabetes mellitus(duration not reported) and osteoporosis.Concomitant products included - venlafaxin(venlafaxine hydrochloride) --/--/2018 to ongoing, vigantoletten(colecalciferol) --/--/2002 to ongoing, digimerck(digitoxin) --/--/2007 to ongoing.On an unknown date in 2014, patient started using novopen 5.On (b)(6) 2022, during use of novopen 5 the patient experienced a very strong hypoglycemia.During this hypoglycaemia the patient was unconscious and got a thoracic vertebrae 3 compression fracture.As a result, two vertebrae were badly damaged due to which the patient was hospitalized on (b)(6) 2022.It was reported that the cartridge can be inserted, but does not hold.Novopen 5 has crack in cartridge holder lock.On an unknown date in (b)(6) 2022, patient stopped using novopen 5 and was discharged on (b)(6) 2022 from the hospital.Patient still has pain from it.It was also reported that the patient treated with analgesic(non-specified) and immobilization by corset.Batch numbers of novopen 5 was reported as fvg8659 batch numbers of protaphane and actrapid were not reported.Action taken to protaphane was not reported.Action taken to actrapid was not reported.The outcome for the event "thoracic vertebrae 3 compression fracture(two vertebrae were badly damaged)(spinal compression fracture)" was not yet recovered.The outcome for the event "very strong hypoglycaemia - patient was unconscious(hypoglycaemic unconsciousness)" was not yet recovered.The outcome for the event "cartridge can be inserted, but does not hold.Crack in cartridge holder lock(device cracked)" was not reported.Investigational result: novopen 5 - batch fvg8659 the product was not returned for examination.A batch record review was found to be normal.Since last submission, the following were updated: -investigational result updated.-eu/ca device, device addendum tabs updated.-event onset date updated.-patient's height, weight and body.-medical history updated.-event start date updated.-reporter causality updated.-hospitalization criteria added and detalis updated.-event spinal compression fracture verbatim updated from "compression fracture(two vertebrae were badly damaged)" to "cthoracic vertebrae 3 compression fracture(two vertebrae were badly damaged)." -concomitant medications were added.-event outcome and start date updated.-treatment recived updated -new suspect drugs , actrapid and protaphane were added.-narrative updated accordingly.Final manufacturer's comment: 08-aug-2022: the suspected device novopen 5 has not been returned to novo nordisk for evaluation.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.With the available limited information regarding the handling of the suspected device, it is not possible to identify a clear root cause in relation to functionality of novopen 5.Of note, patient was using a device which is expired in 2018.Product handling error such as using the dialling clicks to estimate the dose of the insulin can lead to incorrect dosing, resulting in hypo or hyperglycaemia.Patient had spinal compression fracture (probably due to accidental fall) during hypoglycaemic unconsciousness.Company comment: spinal compression fracture is assessed as unlisted event, hypoglycaemiac unconsciousness is assessed as listed event according to the novo nordisk current ccds in protaphane and actrapid.Relevant information on details or circumstances leading to spinal compression fracture, treatment given, outcome of the events and investigation of the faulty device with suspected products are unavailable for complete causality assessment.Of note, patient was using a device which is expired in 2018.Product handling error such as using the dialling clicks to estimate the dose of the insulin can lead to incorrect dosing, resulting in hypo or hyperglycaemia.Patient had spinal compression fracture (probably due to accidental fall) during hypoglycaemic unconsciousness.This single case report is not considered to change the current knowledge of the safety profile of protaphane and actrapid.H3 continued: evaluation summary.Novopen 5 - batch fvg8659.The product was not returned for examination.A batch record review was found to be normal.

• Brand Name: NOVOPEN 5
• 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 ; 8007276500
• MDR Report Key: 14830042
• MDR Text Key: 295116330
• Report Number: 9681821-2022-00050
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/17/2018
• Device Model Number: N/A
• Device Lot Number: FVG8659
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2016
• 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: DIGIMERCK (DIGITOXIN).; VENLAFAXIN (VENLAFAXINE HYDROCHLORIDE).; VIGANTOLETTEN (COLECALCIFEROL).
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 88 KG