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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4; INSULIN DELIVERY DEVICE
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NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4; INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Event Description
Cartridge holder was broken [device breakage].Blood glucose level up to 520 mg/dl [blood glucose increased].Case description: study id: (b)(6).Study description: main objective of the programme is to help patients to understand their diabetes and maintain normal life through qualified educators who offer simple and practical information directly to the patients and also, train patients on how to use their insulin devices and needles etc.The patient's height, weight and body mass index was not reported.This serious solicited report from (b)(6) was reported by a consumer as "cartridge holder was broken(device cracked)" with an unspecified onset date , "blood glucose level up to 520 mg/dl(blood glucose increased)" with an unspecified onset date and concerned a female patient (age not reported) who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", medical history was not provided.On an unspecified date the patient went to hospital as her blood glucose level reached up to 520 mg/dl.By investigation, it was noticed that the cartridge holder was broken.Batch numbers: novopen 4: fvg8798.The outcome for the event "cartridge holder was broken(device cracked)" was not reported.The outcome for the event "blood glucose level up to 520 mg/dl(blood glucose increased)" was not reported.Reporter's causality (novopen 4) - cartridge holder was broken(device cracked) : unknown.Blood glucose level up to 520 mg/dl(blood glucose increased): unknown.Company's causality (novopen 4) - cartridge holder was broken(device cracked): possible.Blood glucose level up to 520 mg/dl(blood glucose increased): unlikely.Investigation result: novopen 4 - batch fvg8798.The product was not returned for examination.The batch documentation was reviewed and found to be normal.Final manufacturer's comment: 22-nov-2021: the suspected device (novopen 4) has not been returned to novo nordisk a/s for the investigation.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.With the available limited information regarding the handling of the suspected device, it is not possible to identify a clear root cause in relation to functionality of novopen 4.Evaluation summary: investigation result: novopen 4 - batch fvg8798.The product was not returned for examination.The batch documentation was reviewed and found to be normal.
 
Event Description
Cartridge holder was broken [device breakage].Blood glucose level up to 520 mg/dl [blood glucose increased].Case description: study id: (b)(6).Study description: main objective of the programme is to help patients to understand their diabetes and maintain normal life through qualified educators who offer simple and practical information directly to the patients and also, train patients on how to use their insulin devices and needles etc.The patient's height, weight and body mass index was not reported.This serious solicited report from (b)(6) was reported by a consumer as "cartridge holder was broken(device cracked)" with an unspecified onset date , "blood glucose level up to 520 mg/dl(blood glucose increased)" with an unspecified onset date and concerned a female patient (age not reported) who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", medical history was not provided.On an unspecified date the patient went to hospital as her blood glucose level reached up to 520 mg/dl.By investigation, it was noticed that the cartridge holder was broken.Batch numbers: novopen 4: fvg8798.The outcome for the event "cartridge holder was broken(device cracked)" was not reported.The outcome for the event "blood glucose level up to 520 mg/dl(blood glucose increased)" was not reported.Reporter's causality (novopen 4) - cartridge holder was broken(device cracked) : unknown.Blood glucose level up to 520 mg/dl(blood glucose increased): unknown.Company's causality (novopen 4) - cartridge holder was broken(device cracked): possible.Blood glucose level up to 520 mg/dl(blood glucose increased): unlikely.Investigation result: novopen 4 - batch fvg8798.The product was not returned for examination.The batch documentation was reviewed and found to be normal.Final manufacturer's comment: 22-nov-2021: the suspected device (novopen 4) has not been returned to novo nordisk a/s for the investigation.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.With the available limited information regarding the handling of the suspected device, it is not possible to identify a clear root cause in relation to functionality of novopen 4.Evaluation summary: investigation result: novopen 4 - batch fvg8798.The product was not returned for examination.The batch documentation was reviewed and found to be normal.
 
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Brand Name
NOVOPEN 4
Type of Device
INSULIN DELIVERY DEVICE
Manufacturer (Section D)
NOVO NORDISK A/S, MEDICAL SYSTEMS
hilleroed,,
DA 
Manufacturer (Section G)
NOVO NORDISK A/S, MEDICAL SYSTEMS
brennum park
hilleroed,, 3400
DA   3400
Manufacturer Contact
p.o. box 846
plainsboro,, NJ 08536
8007276500
MDR Report Key12860604
MDR Text Key286017206
Report Number9681821-2021-00073
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
20-986
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/15/2021
Device Model NumberN/A
Device Catalogue Number185490
Device Lot NumberFVG8798
Was Device Available for Evaluation? No
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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