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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 Inaccurate Delivery (2339); Defective Device (2588)
Patient Problem Hyperglycemia (1905)
Event Date 03/15/2021
Event Type  Injury  
Event Description
(related symptoms if any separated by commas). Hyperglycaemia with blood glucose levels reported: 565-567 mg/dl [hyperglycaemia]. Malfunction of the novopen 4 [device malfunction]. Insulin dose wasn't accurately administered [incorrect dose administered by device]. Use the dialling clicks to estimate the dose of the insulin [wrong technique in product usage process] this serious spontaneous case from pakistan was reported by a consumer as "hyperglycaemia with blood glucose levels reported: 565-567 mg/dl(hyperglycaemia)" beginning on (b)(6) 2021, "malfunction of the novopen 4(device malfunction)" with an unspecified onset date, "insulin dose wasn't accurately administered(incorrect dose administered by device)" with an unspecified onset date, "use the dialling clicks to estimate the dose of the insulin(wrong technique in product usage process)" with an unspecified onset date, and concerned a (b)(6) female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", , actrapid penfill (insulin human) solution for injection, 100 iu/ml (dose, frequency & route used- 8+6+6, subcutaneous) from (b)(6) 2020 and ongoing for "type 2 diabetes mellitus". Patient's height: 152 cm. Patient's weight: (b)(6) kg. Patient's bmi: 17. 313. Dosage regimens: actrapid penfill: (b)(6) 2020 to not reported (dosage regimen ongoing); current condition: type 2 diabetes mellitus (since 1990). On (b)(6) 2021, patient experienced hyperglycaemia with blood glucose levels of 565-567 mg/dl. Patient suspected event was possible due to the malfunction of the novopen 4, therefore patient's insulin dose wasn't accurately administered. It was mentioned that there are no changes in patient's diet or exercise level. Insulin in use was stored at room temperature 20-25 degrees celsius. Cartridge holder was not detached from the pen body and a force was needed to inject and felt different from normal. Batch number of actrapid penfill and novopen 4 has been requested. Action taken to actrapid penfill was reported as no change. The outcome for the event "hyperglycaemia with blood glucose levels reported: 565-567 mg/dl(hyperglycaemia)" was not yet recovered. The outcome for the event "malfunction of the novopen 4(device malfunction)" was not reported. The outcome for the event "insulin dose wasn't accurately administered(incorrect dose administered by device)" was not reported. The outcome for the event "use the dialling clicks to estimate the dose of the insulin(wrong technique in product usage process)" was not reported. Preliminary manufacturer's comment: on 06-apr-2021: the suspected device novopen 4 has not been returned to novo nordisk for evaluation. No conclusion is reached. Product handling error such as wrong technique in product usage process and needle re-use are significant confounding factors which could have contributed to device malfunction and resultant hyperglycaemia. Reporter comment: alternate aetiology of hyperglycaemia : due to the malfunction novopen 4 reuses needle (not specified).
 
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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 Key11626050
MDR Text Key260990414
Report Number9681821-2021-00017
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodePK
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,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
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 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 Received05/06/2021
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: 04/07/2021 Patient Sequence Number: 1
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