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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 Crack (1135); Improper Flow or Infusion (2954)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Event Description
Hyperglycaemia [hyperglycaemia]. Small crack in the cartridge holder that made the piston not work properly [device breakage]. The piston not work properly, thus causing the possible loss of doses. [drug delivery system malfunction]. High levels of ketone bodies [blood ketone body increased]. This serious spontaneous case from (b)(6) was reported by a pharmacist as "hyperglycaemia(hyperglycaemia)" with an unspecified onset date, "small crack in the cartridge holder that made the piston not work properly(device breakage)" with an unspecified onset date, "the piston not work properly, thus causing the possible loss of doses. (drug delivery system malfunction)" with an unspecified onset date, "high levels of ketone bodies(blood ketone body increased)" with an unspecified onset date, and concerned a (b)(6) male patient who was treated with novopen echo (insulin delivery device) from unknown start date for "device therapy", patient's height, weight and body mass index not reported. Medical history was not provided. On an unknown date, the patient started treatment with novopen echo. On an unknown date, the patient experienced hyperglycaemia , exceeding 300 and even 400 mg/dl (treatment details not specified) because the patient noticed a small crack in the cartridge holder that made the piston not work properly, thus causing the possible loss of doses after the pen was disassembled on (b)(6) 2021 the patient was hospitalized due to several days of hyperglycaemia. On (b)(6) 2021, patient discharged from the hospital). Patient also had high levels of ketone bodies (dates not specified). Batch number of novopen echo was dv40072 (non-valid) action taken to novopen echo was not reported. The outcome for the event "hyperglycaemia(hyperglycaemia)" was not reported. The outcome for the event "small crack in the cartridge holder that made the piston not work properly(device breakage)" was not reported. The outcome for the event "the piston not work properly, thus causing the possible loss of doses. (drug delivery system malfunction)" was not reported. The outcome for the event "high levels of ketone bodies(blood ketone body increased)" was not reported. Preliminary manufacturer's comment: 26-jul-2021: the suspected device novopen echo has not been returned to novo nordisk for investigation. No conclusion is reached.
 
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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 Key12273174
MDR Text Key264945666
Report Number9681821-2021-00042
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2016
Device Model NumberN/A
Device Lot NumberDV40072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2014
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: 08/04/2021 Patient Sequence Number: 1
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