• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 3 INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problem Material Integrity Problem (2978)
Patient Problem Hypoglycemia (1912)
Event Type  Injury  
Event Description
Hypoglycemia [hypoglycaemia], unclear dose numbers led to adjusting of a wrong dose [incorrect dose administered], unclear dose numbers/dose degrees were deleted on the novopen 3 [device material issue]. Case description: study id: 1706-novocare programme. 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: (b)(6). Patient's weight: (b)(6). Patient's bmi: 32. This serious solicited report from (b)(6) was reported by a consumer as "hypoglycemia(hypoglycemia)" with an unspecified onset date, "unclear dose numbers led to adjusting of a wrong dose(wrong dose administered)" with an unspecified onset date, "unclear dose numbers/dose degrees were deleted on the novopen 3(device material issue)" with an unspecified onset date and concerned a (b)(6)-month-old female patient who was treated with novopen 3 (insulin delivery device) from unknown start date for "diabetes mellitus", mixtard 30 hm penfill (insulin human) ((insulin human) suspension for injection, 100 iu/ml) (dose, frequency & route used - 42 iu, qd (30-0-12), subcutaneous) (therapy dates - ongoing) from unknown start date and ongoing for "diabetes mellitus". Dosage regimens: novopen 3: mixtard 30 hm penfill: 42 iu, qd (30-0-12). Current condition: diabetes mellitus (30 years ago, type not reported), hypertension (25 years ago), heart problems (25 years ago), nerves inflammation (duration unknown), illness (unspecified, which decreased appetite and was not eating well). Concomitant medications included - concor (bisoprolol fumarate), thiotacid (thioctic acid), asvlrln 100 (non-codable), melga (non-codable) and downovrazol (non-codable). It was reported that patient started using mixtard 30 penfills with novopen 3, 20 years ago. The patient stated on an unknown date that the unclear dose numbers and dose degrees were deleted on the novopen 3 led to adjusting of a wrong dose which caused the event of hypoglycemia. The blood glucose level when patient suffered from hypoglycemia are not available. Batch numbers: novopen 3: asku. Mixtard 30 hm penfill: asku. Action taken to novopen 3 was not reported. Action taken to mixtard 30 hm penfill was not reported. The outcome for the event "hypoglycemia(hypoglycemia)" was recovered. The outcome for the event "unclear dose numbers led to adjusting of a wrong dose(wrong dose administered)" was not reported. The outcome for the event "unclear dose numbers/dose degrees were deleted on the novopen 3(device material issue)" was not reported. Reporter's causality (novopen 3) - hypoglycemia(hypoglycemia): probable. Unclear dose numbers led to adjusting of a wrong dose(wrong dose administered): probable. Unclear dose numbers/dose degrees were deleted on the novopen 3(device material issue) : probable. Company's causality (novopen 3) - hypoglycemia(hypoglycemia) : possible. Unclear dose numbers led to adjusting of a wrong dose(wrong dose administered): possible. Unclear dose numbers/dose degrees were deleted on the novopen 3 (device material issue): possible. Reporter's causality (mixtard 30 hm penfill) - hypoglycemia(hypoglycemia) unlikely. Unclear dose numbers led to adjusting of a wrong dose(wrong dose administered): unlikely. Unclear dose numbers/dose degrees were deleted on the novopen 3(device material issue): unlikely. Company's causality (mixtard 30 hm penfill) - hypoglycemia(hypoglycemia): possible. Unclear dose numbers led to adjusting of a wrong dose(wrong dose administered): possible. Unclear dose numbers/dose degrees were deleted on the novopen 3(device material issue): possible. No further information available. On 27-oct-2020: the suspected device novopen 3 has not been returned to novo nordisk for evaluation. No conclusion has been reached. Elderly age of the patient ((b)(6) years) and underlying diabetes mellitus and other co-morbidities are significant confounding factors for development of hypoglycaemia.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10794588
MDR Text Key217424331
Report Number9681821-2020-00053
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
Report Date 10/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number185290
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2020
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 Treatment Data
Date Received: 11/05/2020 Patient Sequence Number: 1
-
-