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Hyperglycaemic coma [diabetic hyperglycaemic coma], pen wasn't working [device failure], lack of efficacy of insulin [drug ineffective], 1st pen the cartridge holder is broken at the site of fixing it with the mechanical part [device breakage], 2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill [device malfunction].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.Patient's height: (b)(6).Patient's weight: (b)(6).Patient's bmi: (b)(6).This serious solicited report from (b)(6) was reported by a consumer as "hyperglycaemic coma" beginning on (b)(6) 2018, "pen wasn't working" with an unspecified onset date, "lack of efficacy of insulin" with an unspecified onset date, "1st pen the cartridge holder is broken at the site of fixing it with the mechanical part" with an unspecified onset date, "2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill" with an unspecified onset date and concerned a (b)(6) female patient who was treated with novopen 4 (insulin delivery device) from unknown start date to (b)(6) 2018 due to "type 1 diabetes mellitus", novopen 4 (insulin delivery device) from unknown start date to (b)(6) 2018 due to "type 1 diabetes mellitus", actrapid penfill hm(ge) (insulin human) from unknown start date to (b)(6) 2018 due to "type 1 diabetes mellitus" (dose and frequency unknown), mixtard 30 penfill hm (ge) 3.0 ml (insulin human) from unknown start date to (b)(6) 2018 due to "type 1 diabetes mellitus" (dose and frequency unknown).Medical history included type 1 diabetes mellitus (since (b)(6)).On an unspecified date, the patient started mixtard 30 penfill and actrapid penfill with novopen 4.It was reported that 2 novopen 4 pens were not working normally.The cartridge holder of the 1st pen was broken at the site of fixing it with the mechanical part.The piston holder of the 2nd pen did not work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill.On (b)(6) 2018, the patient experienced hyperglycaemic coma as there was a lack of efficacy of the insulin as the pen was not working.The patient was hospitalized in icu (intensive care unit) on the same day and was given unspecified treatment.During hospitalization, the patient was shifted to apidra and another type of insulin (the reporter did not remember it).On (b)(6) 2018, the patient was discharged.Action taken to novopen 4 was reported as product discontinued.Action taken to novopen 4 was reported as product discontinued.Action taken to actrapid penfill hm (ge) was reported as product discontinued.Action taken to mixtard 30 penfill hm (ge) 3.0 ml was reported as product discontinued.The outcome for the event "hyperglycaemic coma" was recovered.The outcome for the event "pen wasn't working" was not reported.The outcome for the event "lack of efficacy of insulin" was not reported.The outcome for the event "1st pen the cartridge holder is broken at the site of fixing it with the mechanical part" was not reported.The outcome for the event "2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill" was not reported.Reporter's causality (novopen 4) - hyperglycaemic coma: probable.Pen wasn't working: probable.Lack of efficacy of insulin: unknown.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: unknown.2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill: unknown.Company's causality (novopen 4) - hyperglycaemic coma: possible.Pen wasn't working: possible.Lack of efficacy of insulin: possible.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: possible.2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill: possible.Reporter's causality (novopen 4) - hyperglycaemic coma: unknown.Pen wasn't working: unknown.Lack of efficacy of insulin: unknown.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: unknown.2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill: unknown.Company's causality (novopen 4) - hyperglycaemic coma: possible.Pen wasn't working: possible.Lack of efficacy of insulin: possible.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: possible.2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill: possible.Reporter's causality (actrapid penfill hm (ge)) - hyperglycaemic coma: probable.Pen wasn't working: probable.Lack of efficacy of insulin: unknown.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: unknown.2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill: unknown.Company's causality (actrapid penfill hm (ge)) - hyperglycaemic coma: possible.Pen wasn't working: possible.Lack of efficacy of insulin: possible.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: possible.2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill: possible.Reporter's causality (mixtard 30 penfill hm (ge) 3.0 ml) - hyperglycaemic coma: probable.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: probable.Lack of efficacy of insulin: unknown.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: unknown.2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill: unknown.Company's causality (mixtard 30 penfill hm (ge) 3.0 ml) - hyperglycaemic coma: possible.Pen wasn't working: possible.Lack of efficacy of insulin: possible.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: possible.2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill: possible.Batch number of actrapid penfill, mixtard 30 penfill and 1st novopen 4 was available.Batch number of 2nd novopen 4 was not available.Company comment: the reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of actrapid penfill and mixtard 30 penfill.
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Event verbatim [preferred term] (related symptoms if any separated by commas).Hyperglycaemic coma [diabetic hyperglycaemic coma].Pen wasn't working [device failure].Lack of efficacy of insulin [drug ineffective].1st pen the cartridge holder is broken at the site of fixing it with the mechanical part [device breakage].2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill [device malfunction].Needle is reused for 4 times, patient left the needle attached to the pen in between injections, insulin was not regularly resuspended (rolled it between hands) before use [wrong technique in product usage process].Case description: this serious solicited report from egypt was reported by a consumer as "hyperglycaemic coma" beginning on (b)(6) 2018, "pen wasn't working" with an unspecified onset date, "lack of efficacy of insulin" with an unspecified onset date, "1st pen the cartridge holder is broken at the site of fixing it with the mechanical part" with an unspecified onset date, "2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill" with an unspecified onset date, "needle is reused for 4 times,patient left the needle attached to the pen in between injections, insulin was not regularly resuspended (rolled it between hands) before use" with an unspecified onset date and concerned a 23 years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date to (b)(6) 2018 due to "type 1 diabetes mellitus", novopen 4 (insulin delivery device) from unknown start date to (b)(6) 2018 due to "type 1 diabetes mellitus", , actrapid penfill hm(ge) (insulin human) from unknown start date to 24-oct-2018 due to "type 1 diabetes mellitus" (dose and frequency unknown), mixtard 30 penfill hm(ge) 3.0 ml (insulin human) from unknown start date to 24-oct-2018 due to "type 1 diabetes mellitus" (dose and frequency unknown), and unspecified needle (non codable) from an unknown start date for type 1 diabetes mellitus.It was reported that patient reused the needle 4 times and left the needle attached to the pen in between injections.The patient did not regularly resuspend (rolled between hands) the insulin suspension before use.The force needed to inject was normal.The patient was trained in the use of novopen 4 by a health care professional.It was reported that the cartridge holder sometimes detached from the pen body.Action taken to unspecified needle was not reported.On 28-oct-2018 the outcome for the event "hyperglycaemic coma" was recovered.Reporter's causality (novopen 4).Hyperglycaemic coma: probable.Pen wasn't working: probable.Lack of efficacy of insulin: unknown.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: unknown.2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill: unknown.Needle is reused for 4 times,patient left the needle attached to the pen in between injections, insulin was not regularly resuspended (rolled it between hands) before use : unknown.Company's causality (novopen 4).Hyperglycaemic coma: possible.Pen wasn't working: possible.Lack of efficacy of insulin: possible.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: possible.2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill : possible.Needle is reused for 4 times, patient left the needle attached to the pen in between injections,insulin was not regularly resuspended (rolled it between hands) before use : possible.Reporter's causality (novopen 4).Hyperglycaemic coma: unknown.Pen wasn't working: unknown.Lack of efficacy of insulin: unknown.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: unknown.2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill: unknown needle is reused for 4 times,patient left the needle attached to the pen in between injections,insulin was not regularly resuspended (rolled it between hands) before use : unknown.Company's causality (novopen 4).Hyperglycaemic coma: possible.Pen wasn't working: possible.Lack of efficacy of insulin: possible.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: possible.2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill : possible.Needle is reused for 4 times,patient left the needle attached to the pen in between injections,insulin was not regularly resuspended (rolled it between hands) before use : possible.Reporter's causality (actrapid penfill hm (ge).Hyperglycaemic coma: probable.Pen wasn't working: probable.Lack of efficacy of insulin: unknown.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: unknown.2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill: unknown.Needle is reused for 4 times, patient left the needle attached to the pen in between injections,insulin was not regularly resuspended (rolled it between hands) before use : unknown.Company's causality (actrapid penfill hm (ge).Hyperglycaemic coma: possible.Pen wasn't working: possible.Lack of efficacy of insulin: possible.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: possible.2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill : possible.Needle is reused for 4 times,patient left the needle attached to the pen in between injections,insulin was not regularly resuspended (rolled it between hands) before use : possible.Reporter's causality (mixtard 30 penfill hm (ge) 3.0 ml).Hyperglycaemic coma: probable.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: probable.Lack of efficacy of insulin: unknown.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: unknown.2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill: unknown.Needle is reused for 4 times,patient left the needle attached to the pen in between injections,insulin was not regularly resuspended (rolled it between hands) before use : unknown.Company's causality (mixtard 30 penfill hm (ge) 3.0 ml).Hyperglycaemic coma: possible.Pen wasn't working: possible.Lack of efficacy of insulin: possible.1st pen the cartridge holder is broken at the site of fixing it with the mechanical part: possible.2nd pen the piston rod didn't work probably as the piston rod moves firstly then becomes stuck and stops before complete pressing on the penfill : possible needle is reused for 4 times,patient left the needle attached to the pen in between injections,insulin was not regularly resuspended (rolled it between hands) before use : possible.Investigation result: product name: actrapid penfill 3 ml 100iu/ml.Batch number: hr7h889.The product was not returned for examination.The complaint has been registered in novo nordisk complaint handling system.Product name: mixtard 30 penfill 3 ml 100 iu/ml.Batch number: gr79851.The product was not returned for examination.The complaint has been registered in novo nordisk complaint handling system.Product name: novopen 4.Batch number: cug2274.The product was not returned for examination.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.Product name: novopen 4.Batch number: unknown.No investigation was possible because neither sample nor batch number was available.Since last submission, the following was updated to the case event of "needle is reused for 4 times, patient left the needle attached to the pen in between injections, insulin was not regularly resuspended (rolled it between hands) before use" added stop date for the event of hyperglycaemic coma updated unspecified needle added.Investigation result updated.Narrative updated accordingly.Company comment: 11-dec-2018: as the device (novopen 4) 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).The reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of actrapid penfill and mixtard 30 penfill.Evaluation summary: product name: novopen 4.Batch number: unknown.No investigation was possible because neither sample nor batch number was available.
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