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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 Mechanical Problem (1384); Use of Device Problem (1670)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) hyperglycemia (random blood glucose reached 600 mg/dl ) [hyperglycaemia] piston rod was stucked in the mechanical part, made the patient didn't take the dose [device failure] patient leaved the needle attached to the pen in between injections with the transculant cap (needlecover) and reused the needle [wrong technique in device usage process]. Case description: study id: (b)(4)-outbound patient calls. Study description: trial title: the objective of the programme is to perform outbound calls to the patients who have received samples of novo nordisk egypt products. This is to confirm that they have received the sample, and verify if they have any problems with regard to the product received, or any problem with regard to diabetes. Patient's weight: (b)(6) kg. Patient's height and body mass index (bmi) were not reported. This serious solicited report from (b)(6) was reported by a consumer as "hyperglycemia (random blood glucose reached 600 mg/dl )" with an unspecified onset date , "piston rod was stucked in the mechanical part, made the patient didn't take the dose" with an unspecified onset date , "patient leaved the needle attached to the pen in between injections with the transculant cap (needlecover) and reused the needle" with an unspecified onset date and concerned a (b)(6)-year-old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date and ongoing due to "type 1 diabetes mellitus". Medical history included type 1 diabetes mellitus (from 20 days). The patient had anaemia from 20 days. Concomitant medications included - actrapid penfill hm(ge) solution for injection, 100 iu/ml, lantus(insulin glargine), rainbow - vit 7. On an unspecified date, 20 days ago, patient suffered from hyperglycemia at the first day of using novopen 4 and her random blood glucose reached to 600 mg/dl because piston rod was stuck in the mechanical part and the patient was unable to take the dose. It was insulin pen problem. At the beginning of hyperglycaemia patient was advised to increase the dose. After that, began to decrease the doses and patient's random blood glucose level in the last weeks estimation (at the time of report), varies between 85mg/dl to 200mg/dl. From 2 days (at the time of report), patient's random blood glucose level returned to the range of 100 to 200 mg/dl after fixing the pen problem. The patient left the needle attached to the pen in between injections with the transculant cap (needlecover). The patient reused the needles. The force needed to inject was normal. The patient used dialling clicks to estimate the dose of the insulin. The patient attached the needle to the pen in a 180 degree angle. The patient stored the insulin in use at room temperature 20-25 degrees celsius. The patient did not recently change from another novopen to the current novopen 4. Patient's mother has been trained in the use of the novopen 4. No recent changes in diet or exercise but the patient is very active. Batch number was available. Action taken to novopen 4 was not reported. The outcome for the event "hyperglycemia (random blood glucose reached 600 mg/dl )" was recovered. The outcome for the event "piston rod was stucked in the mechanical part, made the patient didn't take the dose" was not reported. The outcome for the event "patient leaved the needle attached to the pen in between injections with the transculant cap (needlecover) and reused the needle" was not reported. Reporter's causality ( novopen 4) - hyperglycemia (random blood glucose reached 600 mg/dl ) : possible. Piston rod was stucked in the mechanical part, made the patient didn't take the dose : possible. Patient leaved the needle attached to the pen in between injections with the transculant cap (needlecover) and reused the needle : unknown. Company's causality ( novopen 4) - hyperglycemia (random blood glucose reached 600 mg/dl ) : possible. Piston rod was stucked in the mechanical part, made the patient didn't take the dose : possible. Patient leaved the needle attached to the pen in between injections with the transculant cap (needlecover) and reused the needle : possible. Reporter comment: cause of the event is the novopen 4 problem and not the insulin.
 
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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
Manufacturer Contact
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key8769524
MDR Text Key150542051
Report Number9681821-2019-00040
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
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 06/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number185490
Device Lot NumberHVGN734-1
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2018
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: 07/08/2019 Patient Sequence Number: 1
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