• 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 4 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 4 INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problems Failure to Fire (2610); Infusion or Flow Problem (2964)
Patient Problems Hyperglycemia (1905); Test Result (2695); No Code Available (3191)
Event Date 05/23/2018
Event Type  Injury  
Event Description
High blood sugars [blood glucose increased]. Plunger would not depress and unable to inject as the pens failed [device failure]. High glycosylated hemoglobin (a1c) [glycosylated haemoglobin increased]. Case description: this serious spontaneous case from the united states was reported by a consumer as "high blood sugars" beginning on (b)(6) 2018, "plunger would not depress and unable to inject as the pens failed" beginning on (b)(6) 2018, "high glycosylated hemoglobin (a1c)" with an unspecified onset date, and concerned a (b)(6) -year-old male patient who was treated with novopen 4 (insulin delivery device) from unknown start date due to "type 2 diabetes mellitus" and novopen 4 (insulin delivery device) from unknown start date due to "type 2 diabetes mellitus". Patient height, weight or body mass index not reported. Medical history included type 2 diabetes mellitus (for over 20 years) and hypertension. Concomitant products included - novolin ge nph penfill (insulin human) suspension for injection, 100 iu/ml, novorapid penfill (insulin aspart) solution for injection, 100 u/ml. It was reported that on (b)(6) 2018 patient from (b)(6) had complaint about simultaneous product failures. The plungers on the two novopen 4 failed and would not depress and as a result, the patient experienced high blood sugars and high glycosylated hemoglobin (a1c). This occurred while patient was in (b)(6). It was considered serious diabetic crisis and blood sugar readings were significantly elevated. It was a medical emergency and patient went to see a doctor. On (b)(6) 2018, patient's blood glucose levels were 12. 9 mmol/l, 6. 1 mmol/l, 15. 6mmol/l, 13. 7mmol/l, 18. 3mmol/l and 13mmol/l. On (b)(6) 2018, patient's blood glucose levels were 8. 4mmol/l, 8. 9mmol/l, 11. 8mmol/l, 13. 2mmol/l, 14. 4mmol/l and 13. 1mmol/l. On (b)(6) 2018, patient's blood glucose levels were 11. 8mmol/l, 10. 9mmol/l, 17. 4mmol/l and 11. 0mmol/l. Overall the average for 3 days was 12. 7mmol/l. On an unknown date, patient glycosylated hemoglobin (a1c) values was 9%. It was reported that patient bought novolog disposable pen, which is equivalent to novorapid insulin and used it for 2 days. Patient did not have a similar disposable pen for novalin ge nph so he took only novorapid to control blood sugar. Patient took novorapid disposable pen while in las vegas then when went back to (b)(6) went back on his regular insulins. Action taken to novopen 4 (insulin delivery device) was not reported. Action taken to novopen 4 (insulin delivery device) was not reported. On (b)(6) 2018 the outcome for the event "high blood sugars" was recovered. The outcome for the event "plunger would not depress and unable to inject as the pens failed" was not reported. The outcome for the event "high glycosylated hemoglobin (a1c)" was not reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNOVOPEN 4
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 Key7593477
MDR Text Key110846504
Report Number9681821-2018-00038
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
20-986
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 05/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number185490
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/12/2018
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: 06/12/2018 Patient Sequence Number: 1
-
-