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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 Device (2588); Insufficient Information (3190)
Patient Problem Hypoglycemia (1912)
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas). Nocturnal hypoglycaemia [hypoglycaemia]. Mixed up her two blue novopen echo pens in the night [wrong device used]. Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "nocturnal hypoglycaemia(hypoglycaemia night)" with an unspecified onset date, "mixed up her two blue novopen echo pens in the night (wrong device used)" with an unspecified onset date, and concerned a (b)(6) year old female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", the patient's height, weight and body mass index were not reported. Current condition: type 1 diabetes mellitus (duration not reported). On an unspecified date, reported as sometime ago, the patient mixed up her two blue novopen echo pens in the night and had nocturnal hypoglycaemia so that emergency doctor had to come. Batch number of novopen echo has been requested. The outcome for the event "nocturnal hypoglycaemia(hypoglycaemia night)" was not reported. The outcome for the event "mixed up her two blue novopen echo pens in the night (wrong device used)" 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. Preliminary manufacturer's comment: on 20-nov-2020: the suspected device (novopen echo) has not been returned to novo nordisk for evaluation. No conclusion has been reached. Elderly age of the patient ((b)(6) years) is a significant risk factor for device confusion at night, which could have lead to hypoglycaemia.
 
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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 Key10914492
MDR Text Key219955810
Report Number9681821-2020-00059
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeGM
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,Followup,Followup
Report Date 11/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number185458
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/27/2020 Patient Sequence Number: 1
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