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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S, NOVOPEN 5 INSULIN DELIVERY DEVICE

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NOVO NORDISK A/S, NOVOPEN 5 INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problem Defective Device (2588)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Syncope/Fainting (4411)
Event Type  Injury  
Event Description
Patient almost died [near death experience]. Sugar levels to be all over the place (hypos and hypers) [diabetes mellitus inadequate control]. Faulty pens, jamming part way through, which are stopping and starting [device malfunction]. Infection due to the fact that patient was not receiving correct amount of insulin [infection]. Case description: this serious spontaneous case from the united kingdom was reported by a consumer as "patient almost died(near death experience)" with an unspecified onset date, "sugar levels to be all over the place (hypos and hypers)(loss of control of blood sugar)" with an unspecified onset date, "faulty pens, jamming part way through, which are stopping and starting(device malfunction)" with an unspecified onset date, "infection due to the fact that patient was not receiving correct amount of insulin(infection)" with an unspecified onset date, and concerned a (b)(6)-year-old female patient who was treated with novopen 5 (insulin delivery device) from unknown start date for "device therapy", tresiba flextouch u200 (insulin degludec) solution for injection, 100 iu/ml (dose, frequency & route used: unk, unknown) from unknown start date for "product used for unknown indication", tresiba flextouch u200 (insulin degludec) from unknown start date for "product used for unknown indication", tresiba penfill (insulin degludec) from unknown start date for "product used for unknown indication". Medical history was not provided. Concomitant products included - novorapid penfill(insulin aspart) solution for injection, 100 iu/ml on an unspecified date, the patient had faulty pens, jamming part way through, which are stopping and starting and did not appear to be working. As a result, the patient's blood sugar levels to be all over the place (hypos and hypers), unit and reference range were not reported. The patient also experienced an infection which was down to the fact that the patient was not receiving sufficient insulin. It was also reported that, the products almost killed patient. Batch numbers: novopen 5: kvgy043-1. Tresiba flextouch u200: kzfm803. Tresiba flextouch u200: kzfr092. Tresiba penfill: ls6dh78. Action taken to tresiba flextouch u200 was not reported. Action taken to tresiba flextouch u200 was not reported. Action taken to tresiba penfill was not reported. The outcome for the event "patient almost died(near death experience)" was recovered. The outcome for the event "sugar levels to be all over the place (hypos and hypers)(loss of control of blood sugar)" was not reported. The outcome for the event "faulty pens, jamming part way through, which are stopping and starting(device malfunction)" was not reported. The outcome for the event "infection due to the fact that patient was not receiving correct amount of insulin(infection)" was not reported. This case was re-classified from nonserious to serious on (b)(6) 2021 due to the event "patient almost died". Preliminary manufacturer's comment: 13-jul-2021: the suspected device (novopen 5) has been returned to novo nordisk for evaluation. It revealed that the cap, with the cartridge holder inside separated from the pen body. Investigation is ongoing, no conclusion is reached. 13-jul-2021:the suspected device (tresiba flextouch) has been returned to novo nordisk for evaluation. Investigation is ongoing, no conclusion is reached. Company comment: the event "near death experience" is assessed as unlisted; diabetes mellitus inadequate control is assessed as listed according to the novo nordisk current ccds in tresiba flextouch. Relevant information on medical history, final diagnosis, product investigation results, action taken with tresiba flextouch are unavailable for complete causality assessment. This single case report is not considered to change the current knowledge of the safety profile of tresiba flextouch. "this report includes a foreign device (novopen 5) that is assessed as "similar" to us marketed novopen echo".
 
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Brand NameNOVOPEN 5
Type of DeviceINSULIN DELIVERY DEVICE
Manufacturer (Section D)
NOVO NORDISK A/S,
bagsvaerd,,
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 Key12189175
MDR Text Key262479919
Report Number9681821-2021-00036
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeUK
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
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Lot NumberKVGY043-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2020
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: 07/19/2021 Patient Sequence Number: 1
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