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

Model Number N/A

Device Problems Defective Component (2292); Failure to Deliver (2338); Inaccurate Delivery (2339)

Patient Problem Hyperglycemia (1905)

Event Date 03/23/2023

Event Type  Injury  

Event Description

The patient's treatment time was delayed, and the blood glucose did not decrease significantly [blood glucose increased].Device failure: the piston spring rod could not eject normally [device failure].Piston spring rod could not eject normally [device malfunction].Case description: this serious spontaneous case received via regulatory authority national medical products administration (nmpa), chn from china was reported by a health care professional nos as "the patient's treatment time was delayed, and the blood glucose did not decrease significantly(blood glucose increased)" beginning on (b)(6) 2023, "device failure: the piston spring rod could not eject normally(device failure)" with an unspecified onset date, "piston spring rod could not eject normally(device delivery system malfunction)" with an unspecified onset date, and concerned a 40 years old female patient who was treated with novopen 5 (insulin delivery device) from on (b)(6) 2023 for "lowering blood glucose".Dosage regimens: novopen 5: on (b)(6) 2023 to not reported; current condition: multiple uterine fibroids, increased amount of menstrual blood, prolonged menstrual period, lowering blood glucose, progressive dysmenorrhea procedure: hospitalized (due to progressive dysmenorrhea, increased amount of menstrual blood, and prolonged menstrual period for over 4 years).Concomitant products included: novorapid (insulin aspart) solution for injection, 100 iu/ml 03/23/2023 to unk.This patient was admitted to the hospital on (b)(6) 2023 due to progressive dysmenorrhea, increased amount of menstrual blood, and prolonged menstrual period for over 4 years.The patient was diagnosed with multiple uterine fibroids.Laparoscopic total hysterectomy, bilateral salpingectomy, and pelvic adhesiolysis were performed under combined intravenous and inhalation general anesthesia in our hospital.After admission, the blood glucose was monitored as high as 23.5 mmol/l, and internists were immediately invited for consultation, and the patient was given subcutaneous insulin injection to decrease blood glucose.After multiple adjustments to the insulin dose, the fasting blood glucose was still at 10 mmol/l.According to the dose calculation, a piece of insulin should have been used up, but the doctor found that 200 u of insulin had not been used up.After further investigation, it was found that the insulin syringe had a malfunction, and its piston spring rod could not eject normally, which caused the drug not to be injected normally, and the patient's blood glucose did not decrease significantly.The syringe was immediately replaced, and laparoscopic total hysterectomy, bilateral salpingectomy, and pelvic adhesiolysis surgery were performed the hospital under combined intravenous and inhalation general anesthesia after the patient's blood glucose decreased.Batch number of novopen 5 was unknown.Action taken to novopen 5 was not reported.The outcome for the event "the patient's treatment time was delayed, and the blood glucose did not decrease significantly(blood glucose increased)" was recovered.The outcome for the event "device failure: the piston spring rod could not eject normally(device failure)" was not reported.The outcome for the event "piston spring rod could not eject normally(device delivery system malfunction)" was not reported.References included: reference type: e2b authority number.Reference id#: (b)(4).Reference notes: national medical products administration."this report is for a foreign device that is assessed as "similar" to us marketed novopen echo".Reporter comment: cause analysis: product reason (including package insert, etc.).Cause analysis description: the insulin syringe had a malfunction, and its piston spring rod could not eject normally.Preliminary handling: the syringe was replaced, and the patient's blood glucose decreased.

Event Description

Case description: investigation results: novopen 5 - 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 results updated.Imdrf codes updated.Eu/ca tab updated with relevant fields narrative has been updated accordingly.References included: reference type: e2b authority number reference id#: (b)(4).Reference notes: national medical products administration.Final manufacturer's comment: 31-may-2023: the suspected device novopen 5 has not been returned to novo nordisk for investigation.Batch number of the device unavailable despite repeated efforts to find the same.No batch trend analysis or reference sample analysis performed.No other confounding factors identified.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.This report is for a foreign device that is assessed as "similar" to us marketed novopen echo".

• 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: 16705919
• MDR Text Key: 313011229
• Report Number: 9681821-2023-00050
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

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 Model Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/10/2023
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 06/16/2023
• 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: NOVORAPID (INSULIN ASPART) SOLUTION FOR INJECTION.
• Patient Outcome(s): Hospitalization
• Patient Age: 40 YR
• Patient Sex: Female