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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 Defective Component (2292); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)
Patient Problems Hyperglycemia (1905); No Code Available (3191)
Event Type  Injury  
Event Description
Case description: investigational results: novopen echo® batch number: evg2908-1 the electronic register was checked. No remarks. Visual and functional examinations were performed. Not possible to test the pen with cartridge and needle as the cartridge holder is damaged; confirmed. Both snap connections on the cartridge holder are broken off and it is impossible to mount the cartridge holder on the pen. During development of the fault on the cartridge holder which started with a crack and to the state that the cartridge holder is now in, it is likely that the dosage accuracy was affected at a time during use. Consequently the pen cannot be used. The fault is caused by an error in novo nordisk a/s. Since last submission the case was updated with the following information; investigation results added. Manufacturer comments were added. Narrative updated accordingly. Manufacturer's comment: on (b)(6) 2017: the patient's grandmother is using a syringe to extract the insulin from the cartridge (penfill) causing the patient to experience a hyperglycaemic event, argus case (b)(4). Extracting insulin from a penfill and administrating it with a syringe is recognised as normal use and in the patient leaflet of the novorapid penfill it is stated that product is designed to be used with novo nordisk insulin delivery systems and novofine or novotwist needles. No other serious cases where a cartridge holder has broken both snaps and the user extract insulin from a penfill and administer insulin from a syringe has been reported to novo nordisk. Evaluation summary: name: novopen echo®, batch number: evg2908-1 inv-0326597:inv-0326599:the electronic register was checked. No remarks. Visual and functional examinations were performed. Both snaps are broken off the cartridge holder. Not possible to test the pen with cartridge and needle as the cartridge holder is damaged. Confirmed both snap connections on the cartridge holder are broken off and it is impossible to mount the cartridge holder on the pen. During development of the fault on the cartridge holder which started with a crack and to the state that the cartridge holder is now in, it is likely that the dosage accuracy was affected at a time during use. Consequently the pen cannot be used. The fault is caused by an error in novo nordisk a/s. Name: novorapid® penfill®, batch number: unknown. No investigation was possible, because neither sample nor batch number was available. If possible, please forward the reported product(s) for further investigations.
 
Event Description
Case description: since last submission the case was updated with the following information: manufacturer comments were updated. Manufacturer's comment: (b)(6) 2017: the patient's grandmother is using a syringe to extract the insulin from the cartridge (penfill) causing the patient to experience a hyperglycaemic event, argus case (b)(4). Extracting insulin from a penfill and administrating it with a syringe is recognised as normal use and in the patient leaflet of the novorapid penfill, but the dose accuracy is not equal to the dose accuracy of a inulin delivery pen. It is possible that extraction and injection of insulin from the penfill could have contributed to the experienced adverse event. No other serious cases where a cartridge holder has broken both snaps and the user extract insulin from a penfill and administer insulin from a syringe has been reported to novo nordisk. The suspected pen is part of the affected batches involved in the recall (novo nordisk internal reference #(b)(4)) of novopen echo pens and it cannot be excluded that the malfunctions detected on the returned cartridge holders could have contributed to the experienced adverse events in argus case (b)(4).
 
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) increased blood glucose values [blood glucose increased], crack in cartridge holder lock [device issue], incorrect dosage injected [incorrect dosage administered], novorapid penfill was used with single use syringe [wrong technique in product usage process]. Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "increased blood glucose values" with an unspecified onset date, "crack in cartridge holder lock" with an unspecified onset date, "incorrect dosage injected" with an unspecified onset date and "novorapid penfill was used with single use syringe" with an unspecified onset date and concerned a (b)(6) female patient who was treated with novopen echo (insulin delivery device) from unknown start date due to "device therapy" and novorapid penfill (fast acting insulin aspart) from unknown start date for an unknown indication. Patient's height, weight and body mass index (bmi) were not reported. Medical history included type 1 diabetes mellitus (duration not reported). On an unknown date, patient presented increased blood glucose levels 24 mmol during the use of novopen echo. It was reported that there was a crack in the cartridge holder lock. Novorapid penfill was used with single use syringe by the grandmother and therefore the dosage was incorrect. Action taken to novorapid penfill was not reported. Action taken to novopen echo was not reported. The outcome for the event "increased blood glucose values" was not reported. The outcome for the event "crack in cartridge holder lock" was not reported. The outcome for the event "incorrect dosage injected" was not reported. The outcome for the event "novorapid penfill was used with single use syringe" was not reported. (b)(4).
 
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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
novoprod
p.o. box 846
plainsboro, NJ 08536
MDR Report Key6631962
MDR Text Key110214701
Report Number9681821-2017-00021
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 consumer,foreign
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 05/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2017
Device Model NumberN/A
Device Catalogue Number185458
Device Lot NumberEVG2908-1
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/11/2015
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: 06/09/2017 Patient Sequence Number: 1
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