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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); Inaccurate Delivery (2339)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) blood glucose values dropped so far that he lost consciousness [hypoglycaemic unconsciousness]. The push button was very easy to depress [device malfunction]. Patient thought that nothing was delivered, therefore he injected a second time [extra dose administered]. Fluctuating blood glucose values [blood glucose fluctuation]. Case description: this serious spontaneous case from germany was reported by a pharmacist as "blood glucose values dropped so far that he lost consciousness(hypoglycaemic unconsciousness)" with an unspecified onset date, "the pushbutton was very easy to depress(device component malfunction)" with an unspecified onset date, "patient thought that nothing was delivered, therefore he injected a second time(extra dose administered)" with an unspecified onset date, "fluctuating blood glucose values(blood glucose fluctuation)" with an unspecified onset date, and concerned a 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 was not reported. Medical history was not provided. It was reported that patient had fluctuating blood glucose values during use of novopen echo. As the pushbutton was very easy to depress he thought that nothing was delivered. Patient blood glucose values were elevated and therefore he injected a second time. Patient's blood glucose values dropped so far that patient lost consciousness. On an unknown date patient's blood glucose value was 35 mg/dl and was admitted to hospital. Patient's memory got worse. Batch numbers: novopen echo: gvgf376. The outcome for the event "blood glucose values dropped so far that he lost consciousness(hypoglycaemic unconsciousness)" was recovered with sequelae. The outcome for the event "the pushbutton was very easy to depress(device component malfunction)" was not reported. The outcome for the event "patient thought that nothing was delivered, therefore he injected a second time(extra dose administered)" was not reported. The outcome for the event "fluctuating blood glucose values(blood glucose fluctuation)" was not reported. In order to protect the safety of patient it will, in rare cases, be required to disassemble the medical device immediately in a way where it is not subsequently possible to reassemble it (e. G. Destructive testing or altering of the medical device). The disassembled medical device will be stored with the same retention period as other complaint samples.
 
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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 Key13016968
MDR Text Key285014319
Report Number9681821-2021-00092
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 11/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/07/2019
Device Model NumberN/A
Device Catalogue Number185458
Device Lot NumberGVGF376
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/07/2017
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: 12/16/2021 Patient Sequence Number: 1
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