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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4; INSULIN DELIVERY DEVICE
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NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4; INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problems Defective Component (2292); Inaccurate Delivery (2339); Difficult to Advance (2920)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Event Description
(related symptoms if any separated by commas).Hyperglycemic episode [hyperglycaemia].Np4 not injecting the adjusted dose on one shot [incorrect dose administered by device] problem in np4 and needed force to inject the dose by pressing on the dose button several times [device malfunction].Case description: study id: (b)(6).Study description: main objective of the programme is to help patients to understand their diabetes and maintain normal life through qualified educators who offer simple and practical information directly to the patients and also, train patients on how to use their insulin devices and needles etc.Patient's height: 170 cm.Patient's weight: (b)(6) kg.Patient's bmi: 32.871.This serious solicited report from (b)(6) was reported by a consumer as "hyperglycemic episode(hyperglycemia)" with an unspecified onset date , "np4 not injecting the adjusted dose on one shot(incorrect dose administered by device)" with an unspecified onset date , "problem in np4 and needed force to inject the dose by pressing on the dose button several times(device malfunction)" with an unspecified onset date and concerned a 55 years old male patient who was treated with mixtard 30 (insulin human) (suspension for injection, 100 iu/ml) (dose, frequency & route used - 40 iu, qd, unknown) (therapy dates - ongoing) from unknown start date and ongoing for "type 2 diabetes mellitus", , novopen 4 (insulin delivery device) from unknown start date for "type 2 diabetes mellitus".Current condition: type 2 diabetes mellitus (duration was not reported), hypertensive, cvd.Procedure: stent operation.Concomitant medications included - aspocid(acetylsalicylic acid), clopix(clopidogrel bisulfate), alkapress(amlodipine besilate), aldomet [methyldopa](methyldopa), thiotacid(thioctic acid), gaptin(gabapentin), monomac(ceftriaxone sodium, sulbactam).It was reported that patient's blood glucose level was not controlled for about 3 months.It was reported that there was a problem in novopen 4 and needed force to inject the dose by pressing on the dose button several times.It was also reported that novopen4 was not injecting the adjusted dose on one shot and the patient suffered from hyperglycemic episodes with high fasting blood glucose level of 331 mg/dl, random blood glucose level of 249 mg/dl and his last hba1c was 11 % on 05-sep-2020.Batch numbers: mixtard 30: kr73e96; novopen 4: fvg8045.Action taken to mixtard 30 was not reported.Action taken to novopen 4 was not reported.The outcome for the event "hyperglycemic episode(hyperglycemia)" was not reported.The outcome for the event "np4 not injecting the adjusted dose on one shot(incorrect dose administered by device)" was not reported.The outcome for the event "problem in np4 and needed force to inject the dose by pressing on the dose button several times(device malfunction)" was not reported.Reporter's causality (mixtard 30) - hyperglycemic episode(hyperglycemia): probable.Np4 not injecting the adjusted dose on one shot(incorrect dose administered by device): probable.Problem in np4 and needed force to inject the dose by pressing on the dose button several times(device malfunction): probable.Company's causality (mixtard 30) - hyperglycemic episode(hyperglycemia): possible.Np4 not injecting the adjusted dose on one shot(incorrect dose administered by device): possible.Problem in np4 and needed force to inject the dose by pressing on the dose button several times(device malfunction): possible.Reporter's causality (novopen 4) - hyperglycemic episode(hyperglycemia): probable.Np4 not injecting the adjusted dose on one shot(incorrect dose administered by device): probable.Problem in np4 and needed force to inject the dose by pressing on the dose button several times(device malfunction): probable.Company's causality (novopen 4) - hyperglycemic episode(hyperglycemia): possible.Np4 not injecting the adjusted dose on one shot(incorrect dose administered by device): possible.Problem in np4 and needed force to inject the dose by pressing on the dose button several times(device malfunction): possible.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.References included: reference type: e2b company number.Reference id#: (b)(4).Reference notes: company comment - hyperglycaemia is assessed as listed event according to the novo nordisk current ccds information on mixtard 30.The pharmacological property of the insulin is reduction of blood glucose in the blood which is contrary to the event, hence the causality of the event hyperglycaemia is assessed as unlikely.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30.
 
Event Description
Case description: investigation results.Name: novopen® 4.Batch fvg8045.Visual examination and functional testing were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.Name: mixtard® 30 penfill® 3 ml 100iu/ml.Batch kr73e96.The product was not returned for examination.A reference sample was examined macroscopically, microscopically and analysed chemically.The reference sample was found to be normal.Since last submission, the following information has been updated in the case -investigation results updated -annex b, c, d and g updated.-eu/ca tab and device addendum tab updated.-manufacturer's comment updated.-narrative updated accordingly.References included: reference type: e2b company number reference id#: (b)(4).Reference type: mw 3500a mfr.Rpt.#.Reference id#: 9681821-2020-00054.Reference notes: medwatch 3500a mfr.Report number.Final manufacturer's comment: 29-jan-2021: since no faults were found on the returned device (novopen 4) and only very limited information regarding the patients handling of the suspected device is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse event and thus not possible to find similar incidents to the one reported in argus case (b)(4).Hyperglycaemia is assessed as listed event according to the novo nordisk current ccds information on mixtard 30.The pharmacological property of the insulin is reduction of blood glucose in the blood which is contrary to the event, hence the causality of the event hyperglycaemia is assessed as unlikely.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30.H3 continued: evaluation summary.Investigation results.Name: novopen® 4.Batch fvg8045.Visual examination and functional testing were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.
 
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Brand Name
NOVOPEN 4
Type of Device
INSULIN DELIVERY DEVICE
Manufacturer (Section D)
NOVO NORDISK A/S, MEDICAL SYSTEMS
hilleroed,
DA 
MDR Report Key10813636
MDR Text Key218198182
Report Number9681821-2020-00054
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
PMA/PMN Number
20-986
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,study
Type of Report Initial,Followup
Report Date 10/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/05/2021
Device Model NumberN/A
Device Catalogue Number185490
Device Lot NumberFVG8045
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2020
Date Manufacturer Received01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALDOMET [METHYLDOPA] (METHYLDOPA); ALKAPRESS (AMLODIPINE BESILATE); ASPOCID (ACETYLSALICYLIC ACID); CLOPIX (CLOPIDOGREL BISULFATE); GAPTIN (GABAPENTIN); MONOMAC (CEFTRIAXONE SODIUM, SULBACTAM) , 20 MG; THIOTACID (THIOCTIC ACID)
Patient Outcome(s) Life Threatening;
Patient Age55 YR
Patient Weight95
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