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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 Defective Device (2588)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) hyperglycemia that lead to hospitalization since patient started using mixtard 30 penfills [hyperglycaemia] using the pen wrongly by removing the penfill from the pen [device issue]. Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "hyperglycemia that lead to hospitalization since patient started using mixtard 30 penfills(hyperglycemia)" with an unspecified onset date, "using the pen wrongly by removing the penfill from the pen(device issue)" with an unspecified onset date, and concerned a 792 months old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", , mixtard 30 hm penfill (insulin human) suspension for injection, 100 iu/ml (dose, frequency & route used - 35 iu, qd ( 15 iu morning -20 iu after lunch), subcutaneous) (therapy dates - (b)(6) 2021 to ongoing) from (b)(6) 2021 and ongoing for "diabetes mellitus", patient's height: 160 cm. Patient weight was not reported. Current condition: diabetes mellitus (type unknown), hypertension. Concomitant products included - concor(bisoprolol fumarate), erastapex trio(amlodipine besilate, hydrochlorothiazide, olmesartan medoxomil). On an unknown date, the patient also reported that the she was using the pen wrongly by removing the penfill from the pen to be kept inside the refrigerator after each injection time with no readjusting of the pen by making the piston rod touch the penfill's plug and injecting of a test dose before injecting of the patient's dose. On an unknown date, the patient experienced hyperglycemia. On (b)(6) 2021. The patient was hospitalized due to hyperglycemia. On (b)(6) 2021, blood glucose was 600mg/dl. Patient's fbg level became 180 mg/dl and 2 hours post prandial blood glucose level was 300 mg dl. The patient was discharged on (b)(6) 2021. On (b)(6) 2021 fasting blood glucose was 307 mg/dl batch numbers: novopen 4: kvgy352 mixtard 30 hm penfill: not reported action taken to novopen 4 was not reported. Action taken to mixtard 30 hm penfill was not reported. The outcome for the event "hyperglycemia that lead to hospitalization since patient started using mixtard 30 penfills(hyperglycemia)" was unknown. The outcome for the event "using the pen wrongly by removing the penfill from the pen(device issue)" was not reported. Preliminary manufacturer's comment: (b)(6) 2021: the suspected device novopen 4 has not been returned to novo nordisk for evaluation. No conclusion is reached. Company comment: hyperglycaemia is assessed as listed according to the novo nordisk current ccds in mixtard 30 hm penfill. Elderly age of the patient and underlying medical condition such as diabetes mellitus are significant confounding factors for the development of hyperglycaemia. This single case report is not considered to change the current knowledge of the safety profile of mixtard 30 hm penfill. Reporter comment: mixtard 30 penfill 3 ml 100iu/mli nvalid batch number kr75124.
 
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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 Key12391360
MDR Text Key268940371
Report Number9681821-2021-00048
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeEG
PMA/PMN Number
20-986
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
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 NumberKVGY352
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/23/2020
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: 08/31/2021 Patient Sequence Number: 1
Treatment
CONCOR (BISOPROLOL FUMARATE) ONGOING; ERASTAPEX TRIO 08/06/2021 TO ONGOING
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