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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 Problem Inaccurate Delivery (2339)
Patient Problem Hypoglycemia (1912)
Event Date 11/09/2021
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas). Hypoglycaemic episode blood glucose level 2. 1 mmol/l [hypoglycaemia]. Device malfunction [device malfunction]. Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "hypoglycaemic episode blood glucose level 2. 1 mmol/l (hypoglycaemic episode)" beginning on (b)(6) 2021, "device malfunction (device malfunction)" with an unspecified onset date, and concerned a female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 2 diabetes mellitus", , novofine (needle) from unknown start date for "type 2 diabetes mellitus", mixtard 30/70 penfill (insulin human) suspension for injection, 100 iu/ml (dose, frequency & route used- 16 iu, qd, unknown and regimen #2- 18 iu, qd, unknown) from unknown start date and ongoing for "type 2 diabetes mellitus", concomitant products included - metformin. Patient's height, weight and body mass index (bmi) was not reported. Current condition: type 2 diabetes mellitus (duration was not reported). On an unspecified date in (b)(6) 2021, the patient's blood glucose was 9. 8 mmol/l. On (b)(6) 2021, patient's blood glucose level was 2. 1 mmol/l. It was reported that patient was given lemonade and toast to bring blood glucose levels back up. Patient was given the choice to go to hospital or straight to the local doctor. Patient chose to go to doctor and over there patient's blood glucose level was 2. 9 mmol/l. The physician advised the patient to get a new novopen 4 and the patient obliged. Patient had her diabetes medications changed in the past weeks. Her mixtard 30/70 dose was changed from 16 units last week to 18 units this week and she discontinued her metformin tablets. Batch numbers of novopen 4 and novofine was requested. Action taken to novopen 4 was reported as product discontinued due to ae. Action taken to novofine was reported as no change. Action taken to mixtard 30/70 penfill was reported as no change. On (b)(6) 2021 the outcome for the event "hypoglycaemic episode blood glucose level 2. 1 mmol/l (hypoglycaemic episode)" was recovered. The outcome for the event "device malfunction (device malfunction)" was not reported.
 
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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 Key12907795
MDR Text Key286938262
Report Number9681821-2021-00078
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeAS
PMA/PMN Number
20-986
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2021
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 NumberHVGP048-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2021
Date Manufacturer Received03/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2018
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: 12/01/2021 Patient Sequence Number: 1
Treatment
METFORMIN (METFORMIN).
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