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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 Failure to Deliver (2338); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964); No Flow (2991)
Patient Problem Hyperglycemia (1905)
Event Date 05/12/2018
Event Type  Injury  
Event Description
High blood glucose up to 20 - 23 mmol/l [blood glucose increased]. Insulin didn't go out through the new needles (microfine 4 mm) while the injector testing before injection [device issue]. Suspected the injector of incorrect dosing [incorrect dose administered by device]. Using insulin syringes [wrong technique in product usage process]. Usually take out the cartridge from levemir flexpen and use it in combination with the suspect injector novopen echo [intentional product misuse]. Case description: this serious spontaneous case from russian federation was reported by a health care professional as "high blood glucose up to 20 - 23 mmol/l" beginning on (b)(6) 2018, "insulin didn't go out through the new needles (microfine 4 mm) while the injector testing before injection" beginning on (b)(6) 2018, "suspected the injector of incorrect dosing" beginning on (b)(6) 2018, "using insulin syringes" beginning on (b)(6) 2018, "usually take out the cartridge from levemir flexpen and use it in combination with the suspect injector novopen echo" with an unspecified onset date, and concerned a (b)(6) male patient who was treated with novopen echo (insulin delivery device) from an unknown start date to (b)(6) 2018 due to "diabetes melitus type 1". (b)(6). Medical history included type 1 diabetes mellitus (since (b)(6) 2017). Concomitant products included - levemir flexpen(insulin detemir) solution for injection,. 0024 mol/l. It was reported that patient usually take out the cartridge from levemir flexpen and use it in combination with the suspect injector novopen echo. They do it because of unavailability of 0. 5 dose steps in the levemir penfill. On (b)(6) 2018, the patient's mother noticed that insulin did not pass through the new needles (microfine 4 mm) while the injector testing before injections. She suspected that injector delivered incorrect dose. Therefore on (b)(6) 2018, patient experienced high blood glucose up to 20 - 23 mmol/l. On (b)(6) 2018, the patient was switched from the suspected injector and used insulin syringes and on (b)(6) 2018; his blood glucose was reported as 5. 3 mmol/l additionally it was observed that the patient got recovered from the event. Action taken to novopen echo was reported as product discontinued due to ae. On (b)(6) 2018 the outcome for the event "high blood glucose up to 20 - 23 mmol/l" was recovered. The outcome for the event "insulin didn't go out through the new needles (microfine 4 mm) while the injector testing before injection" was not reported. The outcome for the event "suspected the injector of incorrect dosing" was not reported. The outcome for the event "using insulin syringes" was not reported. The outcome for the event "usually take out the cartridge from levemir flexpen and use it in combination with the suspect injector novopen echo" was not reported. Investigational results: novopen echo batch fvg8996-1. The product was not returned for examination. A batch record review was found to be normal. The complaint has been registered in the novo nordisk complaint handling system. A field safety corrective action (fsca) has been performed for certain pen batches. A recall (novo nordisk (b)(4)) has been initiated on cartridge holders from the relevant affected pen batches. Manufacturer's comment: 15-jun-2018: 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). A field safety corrective action (fsca) has been performed for certain pen batches. A recall (novo nordisk (b)(4)) has been initiated on cartridge holders from the relevant affected pen batches. Reporter comment: hcp's causality between the event and novopen echo is "possible". Evaluation summary: name: novopen echo, batch number: fvg8996-1. The product was not returned for examination. The complaint has been registered in the novo nordisk complaint handling system.
 
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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 Key7654916
MDR Text Key112886519
Report Number9681821-2018-00041
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,Followup
Report Date 06/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2018
Device Model NumberN/A
Device Catalogue Number185458
Device Lot NumberFVG8996-1
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2016
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: 07/02/2018 Patient Sequence Number: 1
Treatment
LEVEMIR FLEXPEN (INSULIN DETEMIR)
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