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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 Deliver (2338)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)
Event Date 01/10/2021
Event Type  Injury  
Event Description
Low blood sugars [blood glucose decreased]. High blood sugars [blood glucose increased]. Novopen echo would not depress medication [device failure]. Case description: this serious spontaneous case from the united states was reported by a consumer as "low blood sugars(blood sugar decreased)" beginning on (b)(6) 2021, "high blood sugars(blood sugar increased)" beginning on (b)(6) 2021, "novopen echo would not depress medication(device failure)" 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 for "device therapy", novopen echo (insulin delivery device) from unknown start date for "device therapy", medical history was not provided. Concomitant products included - novolog penfill(insulin aspart) solution for injection, 100 u/ml, levemir(insulin detemir) solution for injection,. 0024 mol/l treatment included - glucagen hypokit(glucagon). On an unknown date novopen echo did not depress medication. It was reported that the backup pen also did not depress the medication either. Due to both of the pens not administering, the patient was taken to the emergency room on (b)(6) 2021 due to blood sugars dropping very quickly from 140mg/dl to 60mg/dl since after eating a cupcake. On (b)(6) 2021, the patient was almost went to the emergency room again due to high blood sugars of 526mg/dl but healthcare provider decided not to. On an unknown date patient also experienced low blood sugars of 146mg/dl dropping down to as low as 60mg/dl for which the patient had possibly received treatment with glucagon hypo kit. It was also reported that the patient had wheezing, eczema, fever, vomiting and a hard time gaining weight while on the product. Batch numbers: novopen echo: kzgy045 novopen echo: jvgv956 investigation results: name: novopen echo, batch: kvgy045 visual examination and functional testing 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 product was found to be normal. The results were found to comply with specifications. During examination of the product, no irregularities related to the complaint were detected. Name: novopen echo, batch: jvgv956 visual examination and functional testing were performed. 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 was 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 was changed to a new one. The fault was caused by incorrect handling during use of the device. 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 product was found to be normal. The results were found to comply with specifications. References included: reference type: e2b company number. Reference id#: (b)(4). Reference type: mw 3500a mfr. Rpt. #. Reference id#: 9681821-2021-00003. Reference notes: medwatch 3500a mfr. Report number reference type: e2b linked report. Reference id#: (b)(4). Reference notes: same patient and reporter. On 11-mar-2021: novopen echo with new batch number (jvgv956) added as suspect. Final manufacturer's comment: (b)(6) 2021: upon investigation of the returned suspected device novopen echo, batch number kvgy045, it was found to function normally in accordance to set specification and no certain root cause can be identified. No confounding factors. Since no faults were found on the returned device and only very limited information regarding the patient's handling of suspected device is reported in the case, it is therefore not possible to identify a clear root cause for the experienced hyperglycaemia. Final manufacturer's comment: (b)(6) 2021: upon investigating the suspected returned device (novopen echo, batch no. Jvgv956), there was no remark on the piston rod or pen (visual examination). The returned device was found to function normally. 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 can occur if a needle stays on the device in between dosing, in some cases the insulin will leak out through the needle and create an air gab inside the pen, this may cause the needle to clog, this can lead to incorrect dose and the push button might be hard to depress. The patient will not receive any insulin and could experience a hyperglycemic event. The fault is caused by incorrect handling during use of the device. Continued: evaluation summary: name: novopen echo, batch: jvgv956. Visual examination and functional testing were performed. 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 was 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 was changed to a new one. The fault was caused by incorrect handling during use of the device. 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 product was found to be normal. The results were found to comply with specifications.
 
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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
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key11633846
MDR Text Key260780785
Report Number9681821-2021-00018
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/25/2021
Device Model NumberN/A
Device Catalogue Number185459
Device Lot NumberJVGV956
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2019
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: 04/08/2021 Patient Sequence Number: 1
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