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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 Problem Failure to Deliver (2338)
Patient Problems Unspecified Infection (1930); Diabetic Ketoacidosis (2364)
Event Date 11/01/2016
Event Type  Injury  
Event Description
Infection. Acute diabetic ketosis complicated by an infection. Echo pen not delivering his medication (possibly a calibration issue). [device issue]. I was on vacation and do not know if the insulin was stored correctly. Case description: this serious spontaneous case from the united states was reported by a general physician as "acute diabetic ketosis ", " infection", "novoecho pen did not deliver insulin, maybe the calibration stopped working", "i was on vacation and do not know if the insulin was stored correctly" all beginning on (b)(6) 2016, and concerned a (b)(6) male patient who was treated with levemir (insulin detemir) from 2014 and ongoing due to "type 1 diabetes mellitus", novolog penfill (fast acting insulin aspart) from unknown start date and ongoing due to "type 1 diabetes mellitus" and novopen echo (insulin delivery device) from unknown start date due to "type 1 diabetes mellitus". Patient's height, weight and body mass index (bmi) were not reported. Medical history included type 1 diabetes mellitus (duration not reported). Treatment drugs included dextrose (glucose) and saline (sodium chloride). It was reported that the patient was on vacation during end of(b)(6) 2016 and he experienced high blood glucose levels. The patient felt that echopen was not delivering medication (possibly a calibration issue) and also mentioned that insulin was incorrectly stored while he was on vacation. It was reported that on (b)(6) 2016, the patient was hospitalized with blood glucose levels of 600 mg/dl for two night and 3 days. While the patient was in hospital, he was diagnosed with acute diabetic ketosis complicated by an infection. The patient was treated with intravenous dextrose and saline with insulin. Action taken to levemir was reported as no change. Action taken to novolog penfill was reported as no change. Action taken to novopen echo was not reported. On (b)(6) 2016 the outcome for the event "acute diabetic ketosis " was reported as recovered. The outcome for the event "novolog echo pen did not deliver insulin, maybe the calibration stopped working" was not reported. The outcome for the event "i was on vacation and do not know if the insulin was stored correctly" was not reported the outcome for the event "infection" was reported as not reported reporter comment: although the patient felt that the high blood sugars were due to using novolog and levemir, he also stated that it could have been due to an infection, having diabetes for such a long time, the echopen not delivering his medication (possibly a calibration issue), or due to possible incorrect storage temperature of his insulin while on vacation.
 
Event Description
Case description: investigation results: name: novopen echo. Batch number: ev40038. The product was not returned for examination. The batch documentation and non-conformity-related documentation examined. No irregularities recorded therefore no further action. The batch documentation has been reviewed. Nothing abnormal was found. Since last submission the case was updated with the following information: - suspect device expiration date added. - investigation results were added. - manufacturer comment added. Manufacturer comment: received 03-mar-2017: as the novoecho pen 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). Continued: evaluation summary: name: levemir®, batch number: unknown. No investigation was possible, because neither sample nor batch number was available. If possible, please forward the reported product(s) for further investigations. Name: novolog® penfill® 3 ml cartridges 100 units/ml (u-100), batch number: unknown no investigation was possible, because neither sample nor batch number was available. If possible, please forward the reported product(s) for further investigations. Name: novopen® echo®, batch number: ev40038. (b)(4): the product was not returned for examination. If possible, please forward the reported product(s) for further investigations. The complaint has been registered in the novo nordisk complaint handling system. (b)(4): the batch documentation and non-conformity-related documentation examined. No irregularities recorded therefore no further action. The batch documentation has been reviewed. Nothing abnormal was found.
 
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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
novoprod novo nordisk inc.
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key6286082
MDR Text Key66037687
Report Number9681821-2017-00005
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/11/2017
Device Model NumberN/A
Device Catalogue Number185459
Device Lot NumberEV40038
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2015
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: 01/30/2017 Patient Sequence Number: 1
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