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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 Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)
Patient Problems Diabetic Ketoacidosis (2364); No Code Available (3191)
Event Date 04/01/2017
Event Type  Injury  
Event Description
Case description: investigation results: novopen echo rouge - batch evg3010-1. The product was not returned for examination. Manufacturer comment: 24-aug-2017: the suspected pen is part of the pen batches affected of novopen echo recall (novo nordisk internal reference #(b)(4)). 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 (b)(4). Evaluation summary: name: novopen¿ echo¿ rouge, batch number: evg3010-1. (b)(4): the product was not returned for examination. The complaint has been registered in the novo nordisk complaint handling system.
 
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas); diabetic ketoacidosis [diabetic ketoacidosis]; blocked pen [device occlusion]; patient didn't receive any product of novorapid penfill for 3 days previous her hospitalization [drug dose omission]. Case description: this serious spontaneous case from france was initially reported by a consumer and confirmed by medical doctor as "diabetic ketoacidosis" beginning on (b)(6) 2017, "blocked pen" beginning on (b)(6) 2017, "patient didn't receive any product of novorapid penfill for 3 days previous her hospitalization" with an unspecified onset date, and concerned a (b)(6) years old female patient who was treated with novopen echo (insulin delivery device) from unknown start date due to "type 1 diabetes mellitus". (b)(6). Medical history included type 1 diabetes mellitus (duration not reported). Pre-treatment drug included insulin pump since 2010. Concomitant products included - novorapid penfill (insulin aspart)solution for injection, 100 u/ml, lantus (insulin glargine). On an unknown date in (b)(6) 2017, the patient's blood glucose level rose to 5 g/l and did not decrease anymore despite administration of novorapid. Despite dose increased, she presented hyperglycaemia with ketoacidosis and was hospitalized for 2 days. When the patient was discharged from hospital, blood glucose level increased again and the mother noticed that the pen piston was blocked (no product did flow out). The snaps keeping the cartridge holder in place were not cracked. When using a new cartridge and a new needle, the pen re-functioned well again. The blood glucose level was then stabilized. According to the mother, the patient didn't receive any product of novorapid penfill for 3 days previous her hospitalization as the pen was blocked. Action taken to novopen echo was not reported. The outcome for the event "diabetic ketoacidosis" was reported as recovered. The outcome for the event "blocked pen" was not reported. The outcome for the event "patient didn't receive any product of novorapid penfill for 3 days previous her hospitalization" was not reported. Company comment: the suspected pen is part of the pen batches affected of novopen echo recall (novo nordisk internal reference # (b)(4)). Reporter comment: the causal role was assessed as unlikely for insulin but it's caused by pen malfunction. According to the physician, novopen echo malfunctioned with blocked piston.
 
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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 2880
Manufacturer Contact
novo nordisk inc.
p.o. box 846
plainsboro 08536
8007276500
MDR Report Key6788115
MDR Text Key258415838
Report Number9681821-2017-00042
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2017
Device Model NumberN/A
Device Catalogue Number185459
Device Lot NumberEVG3010-1
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2015
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: 08/11/2017 Patient Sequence Number: 1
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