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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 5 INSULIN DELIVERY DEVICE

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NOVO NORDISK A/S NOVOPEN 5 INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problem Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas), patient has been admitted to the hospital [hospitalisation], acute trust her device a novopen 5 has been lost [device issue], they are unable to order novopens from their suppliers as its not something they have ordered before [device dispensing error]. Case description: this serious spontaneous case from the united kingdom was reported by a pharmacist as "patient has been admitted to the hospital(hospitalisation)" with an unspecified onset date, "acute trust her device a novopen 5 has been lost(device issue)" with an unspecified onset date, "they are unable to order novopens from their suppliers as its not something they have ordered before(wrong device dispensed)" with an unspecified onset date, and concerned a female patient (age was not reported) who was treated with novopen 5 (insulin delivery device) from unknown start date for "device therapy". Patient height, weight and body mass index were not reported. Medical history was not provided. On an unknown date, patient has been admitted to the hospital and when being transferred from the acute trust her device a novopen 5 has been lost. It was stated that, they were unable to order novopens from their suppliers as it's not something they have ordered before. It was reported that the caller did not have any other information available at the time of reporting. Batch number of novopen 5 has been requested. Action taken to novopen 5 was not reported. The outcome for the event "patient has been admitted to the hospital(hospitalisation)" was not reported. The outcome for the event "acute trust her device a novopen 5 has been lost(device issue)" was not reported. The outcome for the event "they are unable to order novopens from their suppliers as its not something they have ordered before(wrong device dispensed)" was not reported. Preliminary manufacturer's comment: the suspected device (novopen 5) has not been returned to novo nordisk for evaluation. Relevant information regarding device batch number, insulin used with novopen 5, product handling, storage and use of needle are unavailable. No conclusion is reached. This report is for a foreign device that is assessed as "similar" to us marketed novopen echo. Reporter comment: the caller asked if they can send a replacement. The caller then requested that a rep contacts them.
 
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Brand NameNOVOPEN 5
Type of DeviceINSULIN DELIVERY DEVICE
Manufacturer (Section D)
NOVO NORDISK A/S
bagsvaerd,
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 Key11321065
MDR Text Key238726073
Report Number9681821-2021-00010
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 02/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2021
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: 02/12/2021 Patient Sequence Number: 1
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