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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 3 INSULIN DELIVERY DEVICE

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NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 3 INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problems Defective Component (2292); Inaccurate Delivery (2339)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 01/01/2020
Event Type  Injury  
Event Description
(related symptoms if any separated by commas): unconscious due to severe hypoglycemia [hypoglycaemic unconsciousness], dose scale isn't clear and the piston rod moved [device malfunction], hyperglycemia 400 mg/dl [hyperglycaemia]. 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: 165 cm. Patient's weight: (b)(6) kg. Patient's bmi: 25. 71166210. This serious solicited report from egypt was reported by a consumer as "unconscious due to severe hypoglycemia(hypoglycemic unconsciousness)" beginning on 2020 , "dose scale isn't clear and the piston rod moved (device component malfunction)" with an unspecified onset date , "hyperglycemia 400 mg/dl(hyperglycemia)" beginning on 2020 and concerned a (b)(6) year-old male patient who was treated with novopen 3 (insulin delivery device) from unknown start date for "diabetes mellitus" and mixtard 30 hm penfill (insulin human) suspension for injection, 100 iu/ml (dose, frequency & route used - 50 iu, qd (30-0-20), subcutaneous) from unknown start date and ongoing for "diabetes mellitus", dosage regimens: novopen 3: mixtard 30 hm penfill: 50iu, qd; 40iu, qd; 50iu, qd. Current condition: diabetes mellitus (type not reported and duration since 20 years), psychosis, diabetic retinopathy. Historical condition: hypoglycemia. Concomitant medications included - depakene [valproic acid] (valproic acid), prozac(fluoxetine hydrochloride), risperidone, vitamin b6, vitamin b 12 [vitamin b12 nos] (vitamin b12 nos) ongoing. Treatment medications included - glucose. On an unknown date of 2020 (reported as 1. 5 months ago), patient became unconscious due to severe hypoglycemia and was taken to a hospital. It was reported that patient's novopen 3 dose scale was not clear and the piston rod moved. Patient reported that technical complaints with novopen 3 could have caused hypoglycemic unconsciousness. Patient suspected that the unclear dose scale numbers of the np3 might contribute the occurrence of the event hypoglycemic unconsciousness as he might have taken a wrong dose. Patient was given glucose solution and recovered on the same day. The dose of mixtard then decreased as a sequence with hypoglycemia and the patient suffered from hyperglycemia 400 mg/dl 3 days after the onset date of hypoglycemia so the dose increased again. On an unknown date of 1. 5 or 2 years back, the patient had hypoglycemia, and the patient follow excessive exercise , didn't have as suitable a meal , and took insulin dose and recovered once had the meal without hospitalization. Batch numbers: novopen 3: nscg181. Mixtard 30 hm penfill: kr73e85, kr73e85, kr73e85; action taken to mixtard 30 hm penfill was reported as dose decreased. On an unknown date of 2020 the outcome for the event "unconscious due to severe hypoglycemia (hypoglycemic unconsciousness)" was recovered. The outcome for the event "dose scale isn't clear and the piston rod moved (device component malfunction)" was not reported. The outcome for the event "hyperglycemia 400 mg/dl(hyperglycemia)" was not reported. Reporter's causality (novopen 3) - unconscious due to severe hypoglycemia (hypoglycemic unconsciousness) : possible dose scale isn't clear and the piston rod moved (device component malfunction) : possible hyperglycemia 400 mg/dl(hyperglycemia) : unknown. Company's causality (novopen 3) - unconscious due to severe hypoglycemia (hypoglycemic unconsciousness) : possible dose scale isn't clear and the piston rod moved (device component malfunction) : possible hyperglycemia 400 mg/dl(hyperglycemia) : unlikely. Reporter's causality (mixtard 30 hm penfill) - unconscious due to severe hypoglycemia (hypoglycemic unconsciousness) : probable dose scale isn't clear and the piston rod moved (device component malfunction) : unknown hyperglycemia 400 mg/dl(hyperglycemia) : unknown. Company's causality (mixtard 30 hm penfill) - unconscious due to severe hypoglycemia(hypoglycemic unconsciousness) : possible dose scale isn't clear and the piston rod moved(device component malfunction) : possible hyperglycemia 400 mg/dl(hyperglycemia) : unlikely. 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#: eg-novoprod-770650 reference notes: company comment: hypoglycemic unconsciousness is assessed as listed according to the novo nordisk current ccds information on mixtard 30 hm penfill. Considering the positive temporal association, action taken with mixtard 30 hm penfill, recovery of the event after treatment and pharmacological property of mixtard 30 hm penfill, causal relationship cannot be denied. Patient's underlying medical condition of type2 diabetes mellitus, titration of insulin dosage to treat hyperglycaemia and concomitant use of anti-psychotic medications is a significant confounding factor for the development of hypoglycaemia and its complications. This single case report is not considered to change the current knowledge of the safety profile of mixtard 30 hm penfill. Preliminary manufacturer's comment: 09-dec-2020: the suspected device novopen 3 has not been returned to novo nordisk for evaluation. No conclusion has been reached. Patient's underlying medical condition of type2 diabetes mellitus, titration of insulin dosage to treat hyperglycaemia and concomitant use of anti-psychotic medications is a significant confounding factor for the development of hypoglycaemia and its complications. Reporter comment: anti-psychotic drugs may be one of the etiology of hypoglycemia. Additional dosage regimens: suspect product: 2. Dose, frequency & route used, 3. Therapy dates (if unknown, give duration) 6. Lot # 7. Exp. Date: #1 mixtard 30 penfill hm(ge) 3. 0 ml regimen # 2 40 iu, qd (25-0-15) decreased dose, subcutaneous kr73e85 07/--/2022; #1 mixtard 30 penfill hm(ge) 3. 0 ml regimen # 3 50 iu, qd (30-0-20), subcutaneous ongoing kr73e85 07/--/2022.
 
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Brand NameNOVOPEN 3
Type of DeviceINSULIN DELIVERY DEVICE
Manufacturer (Section D)
NOVO NORDISK A/S, MEDICAL SYSTEMS
hilleroed,
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 Key11030029
MDR Text Key227876738
Report Number9681821-2020-00063
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeEG
PMA/PMN Number
19-938
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,study
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/16/2013
Device Model NumberN/A
Device Catalogue Number185290
Device Lot NumberNSCG181
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2003
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: 12/17/2020 Patient Sequence Number: 1
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