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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 Failure to Fire (2610)
Patient Problem No Code Available (3191)
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) difficult to stabilize diabetes [diabetes mellitus inadequate control]. The pen didn't deliver the indicated dose [incorrect dose administered by device]. Device failure [device failure]. Defective pen [device defective]. Case description: this serious spontaneous case from (b)(6) was reported by a pharmacist as "difficult to stabilize diabetes" with an unspecified onset date, "the pen didn't deliver the indicated dose" with an unspecified onset date, "device failure" with an unspecified onset date, "defective pen" with an unspecified onset date, and concerned a child female patient 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". Patient's height, weight and body mass index not reported. Medical history included type 1 diabetes mellitus (duration not reported). Concomitant products included - novorapid penfill(insulin aspart) solution for injection, 100 u/ml, levemir penfill(insulin detemir) solution for injection,. 0024 mol/l, glucagen(glucagon) powder and solvent for solution for injection, 1 mg on an unknown date, patients had difficulty in stabilizing diabetes, could be due to defective pen didn't deliver the indicated dose, results in hospitalization and was also experiencing malaise, later stabilized. The patient also reported device failure. Patient was discharged on same day. Batch number of novopen echo was available. Action taken to novopen echo was reported as unknown. The outcome for the event "difficult to stabilize diabetes" was recovering/resolving. The outcome for the event "the pen didn't deliver the indicated dose" was not reported. The outcome for the event "device failure" was not reported. The outcome for the event "defective pen" was not reported. Investigational results: name: novopen® echo® rouge, batch number: gvgg159-5. The batch documentation was reviewed. No abnormalities relating to the observed problem were found. The electronic register was checked. Several mitigation codes indicating use of a blocked/ broken needle were present. Visual and functional examinations were performed. The device was tested with a random cartridge and a novo nordisk needle was mounted. During testing it was possible to deliver preparation from the cartridge. The dose accuracy was measured by weighing using a random cartridge. The results were found to comply with specifications. The memory data in the device has revealed that the memory display has shown two lines (- -) after an attempted injection during use. The observed problem is caused by the use of a clogged needle on the pen. After the injection to follow the memory display will function normally again, if the injection needle is changed to a new one. The fault is caused by incorrect handling during use of the device. The batch documentation was reviewed. No abnormalities relating to the observed problem were found. The production interval for the batch gvgg159-5 and hvgm014-6 was about 10 months, at the same time, based on analysis including assembling process, packaging process, warehouse handling process, it was not possible for a 5-item pen mixing into a different batch carton. The packaging batch records of the involved batch numbers were checked. The batch records show that documentation regarding line clearance, control equipment and process checks were found to be acceptable. Batch number gvgg159-5 was packaged on 2017. 11. 04, and hvgm014-6 was packaged on 2018. 08. 30. As can be seen, there is almost 10 months between the packaging of the batches. We can therefore rule out that a mix-up has occurred at novo nordisk (b)(4). The observed problem is due to incorrect handling during use. Name: novopen® echo® rouge, batch number: hvgm014-6. The batch documentation was reviewed. No abnormalities relating to the observed problem were found. The production interval for the batch gvgg159-5 and hvgm014-6 was about 10 months, at the same time, based on analysis including assembling process, packaging process, warehouse handling process, it was not possible for a 5-item pen mixing into a different batch carton. The packaging batch records of the involved batch numbers were checked. The batch records show that documentation regarding line clearance, control equipment and process checks were found to be acceptable. Batch number gvgg159-5 was packaged on 2017. 11. 04, and hvgm014-6 was packaged on 2018. 08. 30. As can be seen, there is almost 10 months between the packaging of the batches. We can therefore rule out that a mix-up has occurred at novo nordisk (b)(4). The observed problem is due to incorrect handling during use. Manufacturer comment: 14-aug-2019: upon investigation of returned novopen echo, the memory data in the device has revealed that the memory display has shown two lines (- -) after an attempted injection during use. The observed problem is caused by the use of a clogged needle on the pen. The device was tested with a random cartridge and a novo nordisk needle was mounted. During testing it was possible to deliver preparation from the cartridge. Continued: evaluation summary. Name: novopen® echo® rouge, batch number: hvgm014-6. The batch documentation was reviewed. No abnormalities relating to the observed problem were found. The production interval for the batch gvgg159-5 and hvgm014-6 was about 10 months, at the same time, based on analysis including assembling process, packaging process, warehouse handling process, it was not possible for a 5-item pen mixing into a different batch carton. The packaging batch records of the involved batch numbers were checked. The batch records show that documentation regarding line clearance, control equipment and process checks were found to be acceptable. Batch number gvgg159-5 was packaged on 2017. 11. 04, and hvgm014-6 was packaged on 2018. 08. 30. As can be seen, there is almost 10 months between the packaging of the batches. We can therefore rule out that a mix-up has occurred at novo nordisk (b)(4). The observed problem is due to incorrect handling during use.
 
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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 Key8915037
MDR Text Key159838531
Report Number9681821-2019-00057
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
Type of Report Initial
Report Date 06/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/01/2020
Device Model NumberN/A
Device Catalogue Number185459
Device Lot NumberHVGM014-6
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2018
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: 08/21/2019 Patient Sequence Number: 1
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