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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN ECHO INSULIN DELIVERY DEVICE

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NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN ECHO INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems No Information (3190); No Code Available (3191)
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas). Landed up at the hospital [hospitalisation]. All 4 pens would not work [device failure]. Case description: this serious spontaneous case from italy was reported by a consumer as "landed up at the hospital" with an unspecified onset date, "all 4 pens would not work" with an unspecified onset date, and concerned a (b)(6) patient who was treated with novopen echo (insulin delivery device) from unknown start date due to "device therapy", novorapid (insulin aspart) from unknown start date due to "drug use for unknown indication" (dose and frequency unknown) , levemir (insulin detemir) from unknown start date due to "drug use for unknown indication" (dose and frequency unknown). Medical history included diabetes. (diagnosed with diabetes at the age of (b)(6)). On an unknown date patient's four pens(novopen echo) did not work and patient was hospitalized. Patient also reported that the brand of needle used was bd micro fine ultra 4 mm (non-codable). Batch number of novopen echo available and novorapid, levemir was not reported. The outcome for the event "landed up at the hospital" was unknown. The outcome for the event "all 4 pens would not work" was not reported. Investigation results: novopen echo: batch hugj234-1. The product was not returned for examination and the reported batch number is not valid. No conclusion can be made without the sample or a valid batch number. Novorapid- batch unknown no investigation was possible, because neither sample nor batch number was available. Levemir- batch unknown no investigation was possible, because neither sample nor batch number was available. Manufacturer comment: 30-sep-2019: as the device (novopen echo) has not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in argus case (b)(4). Hospitalisation is assessed as unlisted according to the novo nordisk current ccds in levemir and novorapid. Relevant information on clinical event due to device failure, investigation of suspected device and treatment given are unavailable for complete causality assessment. This single case report is not considered to change the current knowledge of the safety profile of levemir and novorapid. " evaluation summary: novopen echo®, batch number: hugj234-1. The reported batch number is not valid. No conclusion can be made without the sample or a valid batch number. The product was not returned for examination.
 
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Brand NameNOVOPEN ECHO
Type of DeviceINSULIN DELIVERY DEVICE
Manufacturer (Section D)
NOVO NORDISK A/S, MEDICAL SYSTEMS
hilleroed,
DA
Manufacturer (Section G)
NOVO NORDISK A/S
krogshoejvej 55
bagsvaerd 2880,
DA
Manufacturer Contact
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key9142158
MDR Text Key165551233
Report Number9681821-2019-00064
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 09/02/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2020
Device Model NumberN/A
Device Catalogue Number185458
Device Lot NumberHVGJ234-1
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2018
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: 10/01/2019 Patient Sequence Number: 1
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