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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS ACTRAPID PENFILL (INSULIN HUMAN)

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NOVO NORDISK A/S, MEDICAL SYSTEMS ACTRAPID PENFILL (INSULIN HUMAN) Back to Search Results
Device Problems Labelling, Instructions for Use or Training Problem (1318); Device Difficult to Setup or Prepare (1487)
Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)
Event Date 10/15/2017
Event Type  Injury  
Event Description
Diabetic ketoacidosis [diabetic ketoacidosis], hyperglycemia [hyperglycaemia]. The test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out [device failure]. Did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin [wrong technique in product usage process]. Case description: this serious spontaneous regulatory authority case received via (b)(6) from (b)(6) was initially reported by a consumer and later confirmed by health care professional as "diabetic ketoacidosis" beginning on (b)(6) 2017, "hyperglycemia " with an unspecified onset date, "the test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out" with an unspecified onset date, "did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin" with an unspecified onset date, and concerned a (b)(6) female patient who was treated with two novopen 4 (insulin delivery device) from unknown start date due to "diabetes mellitus", actrapid penfill (insulin human) solution for injection, 100 iu/ml (dose, frequency: 32 iu, qd) from (b)(6) 2017 due to "diabetes mellitus", insulatard penfill (insulin human) suspension for injection, 100 iu/ml (dose, frequency: 84 iu, qd) from (b)(6) 2017 due to "diabetes mellitus". Patient's (b)(6). Patient's height and body mass index: not reported. Medical history included diabetes mellitus (type and duration not reported). Treatment included - insulin (insulin; not specified). The (b)(6), reported to nn that 6 female patients between 10 - 18 years, presented diabetic ketoacidosis, a few days after the patients started using penfill. This case concerns one of the 6 patients. On (b)(6) 2017, the patient experienced several vomits, anorexia, and decay. On (b)(6) 2017, the patient went to the hospital, with thick saliva, vomiting, respiratory rate in 18 x min (breaths per minute) and cardiac (rate) 90 x min (beats per minute). On the same day, the patient's chco3 (bicarbonate) was 16. 1 mmol/l, blood glucose was 11. 0 mmol/l at 10:00 am, pco2 was 25. 7 mmhg, po2 was 71. 8 mmhg and ph was 7. 33 (units not applicable). Two tenths of insulin sc (subcutaneous) was administered. The patient was admitted to intermediate therapy with a diagnosis of diabetic ketoacidosis without an association infectious process. It was reported that when the test was performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out, leading to problems in the application of the medication causing hyperglycemia. Also, it was reported that the patient did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin. On an unspecified date, the patient recovered from hyperglycaemia and then the device was changed and the patient was retrained in the use of penfill and novopen 4. The patient's mother reported that the patient knew how to administer the medication and she helped sometimes. The medication always was kept cold; they complied with the administration of the air before administration, counted 6 seconds before extracting the needle and made a previous determination of glucose. Action taken to novopen 4 was not reported. Action taken to actrapid penfill was product discontinued. Action taken to insulatard penfill was product discontinued. The outcome for the event "diabetic ketoacidosis" was not recovered. The outcome for the event "hyperglycemia " was recovered. The outcome for the event "the test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out" was not reported. The outcome for the event "did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin" was not reported. This case is linked to (b)(4) (same reporter). Investigation result: name: insulatard penfill 100 iu/ml, batch number: fs61b38. The complaint had been registered in the novo nordisk complaint handling system and a medical evaluation has been performed. The product was not returned for examination. Name: actrapid penfill 100 iu/ml, batch number: fs61b39. The product was not returned for examination. The complaint had been registered in the novo nordisk complaint handling system. No further information available. Reporter comment: the (b)(6) classified the events as related to novopen 4, not to the insulins (actrapid and insulatard). In this case the (b)(6) could see insecurity when explaining the steps for administration. All the patient's generally re-use the needles for the application of the medication. The functioning tests were performed with new needles and with 1 or 2 previous uses. In the case of administration of the medication for each patient, the needle was used up to 3 times each. In the practical demonstration of the devices in the room, individually with each patient, it was possible to witness the outflow of insulin before the administration of the drug and when the action was repeated without disassembling the needle and putting the supposed dose to be injected, there was no flow, evidencing that the spring did not exert any pressure on the penfil, although the clicks indicator returned to zero. All the patients reported that they liked the administration of this insulin because it does not burn and this may be the reason why they did not realize they did not receive the medication. In the individual interviews, only one girl said that she did not withdraw the needle at the end of the administration of the nph insulin when she used a new one in the first administration in the morning because she would use it in the remaining two applications of the day, but she always performed the disinfection. At the time it was recommended to all patients that they should always remove the needle using the established technique. No patient and family member reported that they had to make a different force to inject, making it easy to operate the dose button. All the patients used insulin suspension and stated that they always performed the re-suspension because they know it was the same type of insulin. The patient's as well as the family members had been trained by the pharmacist who carried out the dispensing of pen in the hospital pharmacy, who indeed was trained by the provincial pharmacoepidemiologist, who was present at the training carried out by the firm. In this regard we inform you that during the monitoring of patients until discharge, were visited daily in the different services to verify their evolution and it was possible to verify with each of them the status of each device in a personal way and the mastery of the techniques of use, in a practical way. This exchange served as a new training because at the time of delivery of the device in the hospital pharmacy, both the patient and the family received training for the use of it by the licensees in charge. The device was never delivered to family members if patients were not present. It was valid to point out that several of the patients had received a first training months before, during their participation in the provincial camp for diabetic children which takes place annually in the summer vacation period. From this first training there was much expectation with the beginning of the use of the new method of administration of insulins. None of the patient's reported changes in diet. The entire patient's inserted needles into the pen at a 180 degree angle and they all showed knowledge related to the needle insertion angle. It was always clarified in the trainings that although the manufacturer recommends storage at room temperature, in (b)(6) it is never less than 30 degrees therefore, we recommended placing the penile near the water pommel that each one carries to the school, or keeping it in cool place at home. All the necessary training actions were carried out for patients and relatives by the pharmacoepidemiology network. All the patients participated in the presentation of the product by the firm. Also there was a training given to municipal pharmacoepidemiologists, hospital pharmacists and community pharmacies responsible for dispensing the device and the penfill. Manufacturer's comment/company comment: 19-mar-2018: as the device novopen 4 has not been returned to novo nordisk a/s for investigation and 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 (b)(4). In this case the reported events are listed. This single case report is not considered to change the current knowledge of the safety profile of actrapid and insulatard. Reporter comment: (b)(6) classified the events as related to novopen 4, not to the insulins (actrapid and insulatard).
 
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Brand NameACTRAPID PENFILL (INSULIN HUMAN)
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 Key7698570
MDR Text Key114324007
Report Number9681821-2018-00045
Device Sequence Number102
Product Code ---
Reporter Country CodeCU
PMA/PMN Number
20-986
Number of Events Reported1
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 02/01/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received07/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/18/2018 Patient Sequence Number: 1
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