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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 Problems Break (1069); No Flow (2991)
Patient Problems Diarrhea (1811); Malaise (2359); Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Sickness [malaise], diarrhea [diarrhoea], diabetic ketoacidosis [diabetic ketoacidosis], cartridge holders had failed and stopped letting out insulin [device failure], pen was broken [device breakage]. Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "sickness" with an unspecified onset date, "diarrhea" with an unspecified onset date, "diabetic ketoacidosis" with an unspecified onset date, "cartridge holders had failed and stopped letting out insulin" with an unspecified onset date, "pen was broken" with an unspecified onset date, and concerned a female patient (age not reported) who was treated with novopen echo (insulin delivery device) from unknown start date due to "device therapy", novopen echo (insulin delivery device) from unknown start date due to "device therapy", novorapid penfill (insulin aspart) from unknown start date due to "drug use for unknown indication" (dose and frequency unknown). Patient's height,weight and body mass index were not reported. Medical history included type 1 diabetes mellitus (duration not reported) concomitant products included - needle, unspecified (needle). On an unspecified date, the patient developed sickness, diarrhea and was hospitalised due to faulty pens. The cartridge holder of one pen had failed and stopped letting out insulin. The other pen was broken. On an unknown date the patient experienced diabetic ketoacidosis. Batch number of novopen echo and novorapid was available. Action taken to novopen echo was not reported. Action taken to novopen echo was not reported. Action taken to novorapid penfill was not reported. The outcome for the event "sickness" was not reported. The outcome for the event "diarrhea" was not reported. The outcome for the event "diabetic ketoacidosis" was not reported. The outcome for the event "cartridge holders had failed and stopped letting out insulin" was not reported. The outcome for the event "pen was broken" was not reported. Reporter comment: the patient did not change the needle after every injection and stored the device with needle attached.
 
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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 Key8289808
MDR Text Key134503209
Report Number9681821-2019-00007
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/06/2016
Device Model NumberN/A
Device Catalogue Number185458
Device Lot NumberDUG2054
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/06/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number00000-7/3/17-001-R

Patient Treatment Data
Date Received: 01/30/2019 Patient Sequence Number: 1
Treatment
NEEDLE, UNSPECIFIED (NEEDLE) N/A
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