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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 Inaccurate Delivery (2339); Calibration Problem (2890)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 10/03/2020
Event Type  Injury  
Event Description
Event verbatim: hypoglycemic crisis and passed out [hypoglycaemic unconsciousness]; novopen echo is out of calibration, and is applying more insulin than it should [incorrect dose administered by device]. Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "hypoglycemic crisis and passed out(hypoglycemic unconsciousness)" beginning on (b)(6) 2020, "novopen echo is out of calibration, and is applying more insulin than it should(incorrect dose administered by device," with an unspecified onset date, and concerned a (b)(6)- year old male patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", fiasp penfill (insulin aspart) solution for injection, 100 u/ml (dose, frequency & route used - not more than 2 iu, unknown) from unknown start date for "type 1 diabetes mellitus". (b)(6). Current condition: type 1 diabetes mellitus (duration not available). Concomitant products included novofine 32g 4mm(needle). It was reported that novopen echo was out of calibration, and was applying more insulin than it should and for that reason the patient had a severe hypoglycemic crisis (18mg/dl) on (b)(6) 2020. The patient was given sachet honey. On (b)(6) 2020, the patient passed out, the mother gave whole milk with sugar. It was reported that the patient had recovered after (b)(6) 2020. The needles are not reused and the pen was not stored with the needle attached. The patient does not use concomitant medications, and has no relevant medical history. Batch numbers: novopen echo: jvgr452-1; fiasp penfill: asku. Action taken to novopen echo was not reported. Action taken to fiasp penfill was not reported. On (b)(6) 2020, the outcome for the event, "hypoglycemic crisis and passed out(hypoglycemic unconsciousness)" was recovered. The outcome for the event "novopen echo is out of calibration, and is applying more insulin than it should (incorrect dose administered by device)" 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 dis-assembled 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 Key10778117
MDR Text Key216846984
Report Number9681821-2020-00051
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeBR
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Model NumberN/A
Device Catalogue Number185459
Device Lot NumberJVGR452-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/03/2020 Patient Sequence Number: 1
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