MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 4; INSULIN DELIVERY DEVICE

Catalog Number 185490

Device Problem Break (1069)

Patient Problems Hyperglycemia (1905); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Pain (1994); Weakness (2145); Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Fault on novopen 4 (pen had its piston rod damaged) [device damage].([diabetic ketoacidosis], [incorrect dose administered by device)}.Blood glucose is wavering [blood glucose fluctuation].Blood glucose increased [blood glucose increased].Case description: does the incident represent a serious public health threat: no.This serious spontaneous regulatory authority (anvisa) case reported by a consumer from (b)(6), concerns a (b)(6) female patient with "type 1 diabetes mellitus", who was treated with novolin n penfill (long acting human insulin) using novopen 4 (insulin delivery device) and reported "fault on novopen 4 (pen had its piston rod damaged)"."injected an incorrect dose of novolin n penfill", "ketoacidosis", "blood glucose increased" beginning on (b)(6) 2014, and "blood glucose is wavering" beginning on an unknown date.Patient's height: 152 cm.Medical history includes type 1 diabetes mellitus (since she was (b)(6) old).The patient does not have a relevant medical history and does not use concomitant medications.The patient's current condition includes infection (lung infection or urine (non conclusive diagnosis) and diabetic neuropathy.The patient has been using novolin n penfill with novopen for 15 years.It was reported that the patient was hospitalized at icu between (b)(6) 2013, due to ketoacidosis.Due to ketoacidosis, the patient had facial ischemia of the left hand, her face was hardened.It was reported that the patient had a novopen 3 and due to its expiration (she bought it more than 5 years ago) she bought a novopen 4 on (b)(6) 2013 (batch number bug1380) to inject human insulin twice a day.After seven days of use, the pen had its piston rod damaged, no insulin was delivered anymore.Due to this fault, the correct dose was not being injected and patient's blood glucose reached 395 mg/dl on (b)(6) 2014.This was the first use of the cartridge and the pen was new, it happened in the first use of the pen.On (b)(6) 2014, it was reported that due to ketoacidosis, the patient had facila ischemia of the left hand, her face was hardened.It was reported that the patient had a novopen 3 and due to tis expiration (she bought it more than 5 years ago) she bought a novopen 4 on (b)(6) 2013 (batch number bug1380) to inject human insulin twice a day.After seven days of use, the pen had its piston rod damaged, no insulin was delivered anymore.Due to this fault, the correct does was not being injected and patient's blood glucose reached 395 mg/dl on (b)(6) 2014.This was the first use of the cartridge and the pen was new, it happened in the first use of the pen.On (b)(6) 2014, it was reported that due to ketoacidosis, the patient experienced diabetic neuropathy and was also experiencing a lot of pain resulting from inflammation of the nerves.At the hospital, the patient used antibiotics due to suspected lung infection or urine (no conclusive diagnosis).The patient received replacement of minerals such as magnesium, sodium and nph human insulin to control blood glucose, and regular insulin (novorapid) to correct blood glucose peaks.The patient had not achieved glycaemic control, her blood glucose was wavering.Additionally, the patient was very weak.In the mornings the patient had hypoglycaemia: (b)(6) 2014 was 42mg/dl; (b)(6) 2014 was 68mg/dl; (b)(6) 2014 was 52mg/dl, (b)(6) 2014 was 51mg/dl; (b)(6) 2014 was 77mg/dl and (b)(6) 2014 was 74mg/dl.In the end of afternoon, around 17:00h, she presented blood glucose levels of 230 and 270 mg/dl.In (b)(6) 2014, the dose of novolin n penfill was changed being 35iu in the morning and 25iu in the evening.On (b)(6) 2014, the patient started to use janumet 50/850mg 1 tab daily to assist in glycemic control and thyoctacid 600h for the treatment of diabetic neuropathy.It was reported that since (b)(6) 2013, due to neuropathy, that has affected limbs, the patient's mother was injecting insulin for her.Before hospitalization, patient performed injections alone, without help.The operator did not receive a train, but has read the leaflet and manual.The device has not been tested by its function.The patient did not know the brand name of the needles used, but the same needle was reused twice.After discharge, the doctor recommended the implementation of regular insulin if blood glucose was above 250mg/dl, like the following: if the blood glucose was above 250mg/dl, 6 iu is injected and she measures blood glucose 1 hour after the application, if it stays above 250mg/dl, she needs to inject more 2ui, and she must not exceed 10 ui/daily.The patient performed a serious treatment; she was followed by a nutritionist.Action taken to novolin n penfill and novopen 4 was not reported.The outcome of the event "ketoacidosis" was reported as recovered.The outcome of the event "blood glucose increased" was reported as not yet recovered.The outcome of the events "fault on novopen 4 (pen had its piston rod damaged)" and "injected an incorrect dose of novolin n penfill" was not reported.The outcome of the event "blood glucose is wavering" was not reported.Reporter comment: the patient's mother wanted to know about the safety of the product because her daughter needs to inject two doses of insulin daily and she cannot face this situation again.She was worried about her daughter's life and this fault put her life at risk.She does not allow us to contact patient's doctor and allows us to contact her later.The sample will not be returned for investigation, it was returned for the drugstore where she received a replacement.

• Brand Name: NOVOPEN 4
• 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; plainsboror, NJ 08536 ; 6099875831
• MDR Report Key: 3627985
• MDR Text Key: 4185812
• Report Number: 9681821-2014-00003
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Type of Report: Initial
• Report Date: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/10/2017
• Device Catalogue Number: 185490
• Device Lot Number: BUG1380
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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: EXP DATE: 05/31/2015; NOVOLIN N PENFILL (INSULIN HUMAN) SUSPENSION FOR; 25IU IN THE EVENING), SUBCUTANEOUS, LOT# CS6B765; NOVOLIN N PENFILL REGIMEN #2; DOSE: 60IU, QD (BEING 35IU IN THE MORNING) AND,; DOSE: 40 IU, QD (20 IU IN AT NIGHT), SUBCUTANEOUS; INJECTION, 1000IU/ML,
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 28 YR
• Patient Weight: 37