| Device Problems
Crack (1135); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Cataract (1766); Glaucoma (1875); Hyperglycemia (1905); Retinal Injury (2048); Visual Impairment (2138)
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] (related symptoms if any separated by commas).Glass haemorrhage to maintain the retina [retinal haemorrhage].Blindness [blindness].High blood glucose level [blood glucose increased].Piston rod of novopen 3 (yug0804) did not press on the penfill [device malfunction].Penfill holder of novopen 3 (yug0804) was broken [device breakage].Np3 which did not inject his dose [device failure].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "glass haemorrhage to maintain the retina" with an unspecified onset date, "blindness" with an unspecified onset date, "high blood glucose level" with an unspecified onset date, "piston rod of novopen 3 (yug0804) did not press on the penfill" with an unspecified onset date, "penfill holder of novopen 3 (yug0804) was broken" with an unspecified onset date, "np3 which did not inject his dose" with an unspecified onset date, and concerned a (b)(6)-year-old male patient who was treated with mixtard 30 hm penfill (insulin human) from unknown start date and ongoing due to "diabetes mellitus" (regimen #1 dose and frequency 15 u, bid, regimen #2 dose and frequency 7-8u/morning & 12 u/afternoon), novopen 3 (insulin delivery device) from unknown start date due to "device therapy", novopen 3 (insulin delivery device) from unknown start date due to "device therapy".Patient's height: (b)(6); patient's weight: (b)(6); patient's body mass index: not reported.Medical history included diabetes mellitus (since 200 and type unknown), hypertension and eye pressure.Patient was not suffering from any other chronic diseases.Pre-treatment included: diamicron.Concomitant products included - concor (bisoprolol fumarate) ongoing , trental (pentoxifylline) ongoing, octatron (ascorbic acid, betacarotene, bioflavonoids, biotin, molybdenum amino acid chelate, selenium amino acid chelate, tocopherol, zinc amino acid chelate) ongoing and twinzol (dorzolamide hydrochloride, timolol maleate) ongoing.On an unknown day, novopen 3 (tug0329) piston rod did not press on the penfill, however, it moved normally out of the mechanical part when pressed on the dose button without putting the penfill.In addition to this, the penfill holder of novopen 3 (yug0804) was also broken.On an unknown date (2 months and 10 days ago), the patient underwent a surgery in both of eyes to change the eye glass due to glass haemorrhage to maintain the retina and that surgery was due to high blood glucose level due to the problem in his novopen 3 which did not inject the dose and patient is now prevented from vision by the order of hcp's instructions and said that the patient was blind until further interference from the ophthalmologist.Patient's average random blood glucose level now ranged between 100-270 mg/dl and patient always tried to be careful to keep it between 100-120 mg/dl.Batch numbers of all suspect products were available.Action taken to mixtard 30 hm penfill was not reported.Action taken to novopen 3 was not reported.Action taken to novopen 3 was not reported.The outcome for the event "glass haemorrhage to maintain the retina" was not yet recovered.The outcome for the event "blindness" was not yet recovered.The outcome for the event "high blood glucose level" was not reported.The outcome for the event "piston rod of novopen 3 (yug0804) did not press on the penfill" was not reported.The outcome for the event "penfill holder of novopen 3 (yug0804) was broken" was not reported.The outcome for the event "np3 which did not inject his dose" was not reported.Investigation results: name: mixtard® 30 penfill® 3 ml 100iu/ml.Batch gr79849.The product was not returned for examination.A reference sample was examined macroscopically and microscopically.Parameters identity, assay and degradation were also performed.The reference sample was found to be normal.The results were found to comply with specifications.During investigation it has not been possible to detect any irregularities related to the complaint on a reference sample of the batch in question.Name: novopen® 3; batch tug0329; the product was not returned for examination.The batch documentation was reviewed with focus on efficacy and delivery.No abnormalities relating to the observed problem were found.Nothing abnormal was found.Name: novopen® 3; batch yug0804; the product was not returned for examination.The batch documentation was reviewed with focus on efficacy and delivery.No abnormalities relating to the observed problem were found.Nothing abnormal was found.Manufacturer comment: 06-nov-2018: as the device (novopen 3) 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).In this case the reported events retinal haemorrhage, blindness are considered unlisted and the event of blood glucose increased is considered listed, events of retinal haemorrhage leading to blindness requiring an eye surgery are not uncommon in patients with underlying uncontrolled diabetes mellitus.Blindness may be due to the underlying diabetic complications such as diabetic retinopathy.However more details are needed for the proper medical evaluation.This single case does not change the safety profile of mixtard.Reporter comment: patient is not suffering from any other chronic diseases.Evaluation summary: investigation results: name: novopen® 3, batch tug0329.The product was not returned for examination.The batch documentation was reviewed with focus on efficacy and delivery.No abnormalities relating to the observed problem were found.Nothing abnormal was found.
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Event Description
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Event verbatim [preferred term] (related symptoms if any separated by commas) glass haemorrhage to maintain the retina [retinal haemorrhage] lost 90 % of the vision by his right eye [visual impairment] glaucoma in the right eye [glaucoma] cataract in the left and right eye [cataract] high blood glucose level [blood glucose increased] piston rod of novopen 3 (yug0804) did not press on the penfill [device malfunction] penfill holder of novopen 3 (yug0804) was broken [device breakage] np3 which did not inject his dose [device failure] use the dialling clicks to estimate the dose of the insulin [wrong technique in device usage process] kept his insulin in use in the refrigerator [product storage error] case description: this serious spontaneous case from egypt was reported by a consumer as "glass haemorrhage to maintain the retina" with an unspecified onset date, "lost 90 % of the vision by his right eye" with an unspecified onset date, "glaucoma in the right eye" with an unspecified onset date, "cataract in the left and right eye" with an unspecified onset date, "high blood glucose level" with an unspecified onset date, "piston rod of novopen 3 (yug0804) did not press on the penfill" with an unspecified onset date, "penfill holder of novopen 3 (yug0804) was broken" with an unspecified onset date, "np3 which did not inject his dose" with an unspecified onset date, "use the dialling clicks to estimate the dose of the insulin" with an unspecified onset date, "kept his insulin in use in the refrigerator" with an unspecified onset date, and concerned a 68-year-old male patient who was treated with mixtard 30 hm penfill (insulin human) from unknown start date and ongoing due to "diabetes mellitus" (regimen #1 dose and frequency 15 u, bid, regimen #2 dose and frequency 7-8u/morning & 12 u/afternoon), novopen 3 (insulin delivery device) from unknown start date due to due to "diabetes mellitus", novopen 3 (insulin delivery device) from unknown start date due to due to "diabetes mellitus".Medical history included diabetes mellitus (since 2000 and type unknown), hypertension.On an unknown date, patient had high blood glucose level due to the problem in his novopen 3 which did not inject the dose.The elevated blood glucose level caused high eye pressure that lead to haemorrhage.On an unknown date (2 months and 10 days ago), the patient underwent a surgery in both the eyes to change the eye glass due to glass haemorrhage to maintain the retina, change the vitreous body and treat the glaucoma and cataract in the right eye and only cataract of the left eye.After the surgery, on an unknown date, patient lost 90% of the vision by his right eye and his left eye still needed more medical interference.On an unknown date, patient's blood glucose level was still uncontrolled.Patient was already directed to one of novocare centers where he replaced one of the novopen 3.It was reported that dialling clicks were used to estimate the dose and the insulin was stored in the refrigerator.Action taken to mixtard 30 hm penfill was reported as no change.The outcome for the event "glass haemorrhage to maintain the retina" was not yet recovered.The outcome for the event "lost 90 % of the vision by his right eye" was not yet recovered.The outcome for the event "glaucoma in the right eye" was not reported.The outcome for the event "cataract in the left and right eye" was not reported.The outcome for the event "high blood glucose level" was not recovered.The outcome for the event "piston rod of novopen 3 (yug0804) did not press on the penfill" was not reported.The outcome for the event "penfill holder of novopen 3 (yug0804) was broken" was not reported.The outcome for the event "np3 which did not inject his dose" was not reported.The outcome for the event "use the dialling clicks to estimate the dose of the insulin" was not reported.The outcome for the event "kept his insulin in use in the refrigerator" was not reported.Since last submission, the following has been updated in the case -'eye pressure' removed from medical history.-action taken to the suspect 'mixtard 30 penfill' was updated to 'no change' -'mixtard 30 penfill' dechallenge and rechallenge updated -training received updated as 'no' -events of 'glaucoma in the right eye', 'cataract in the left and right eye', 'use the dialling clicks to estimate the dose of the insulin' and 'kept his insulin in use in the refrigerator' added.-event verbatim and coding of 'he is blind' updated.-patient and device codes updated -reporter comment updated -manufacturer comment updated -narrative updated accordingly.Furthermore, a correction was made.Since last submission of the case, the following has been corrected: -the batch number in section h3 evaluation summary has been corrected to yug0804.Manufacturer comment: 07-dec-2018: as the device (novopen 3) 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 argus case 626512.In this case the reported events retinal haemorrhage, glaucoma, cataract, blindness are considered unlisted and the event of wrong technique in device usage process, product storage error and blood glucose increased is considered listed.Events of retinal haemorrhage leading to blindness requiring an eye surgery are not uncommon in patients with underlying uncontrolled diabetes mellitus.Blindness may be due to the underlying diabetic complications such as diabetic retinopathy, glaucoma and cataract.However more details are needed for the proper medical evaluation.This single case does not change the safety profile of mixtard.Reporter comment: patient is not suffering from any other chronic diseases.Alternative aetiology: patient was under stress.Continued: evaluation summary investigation results: name: novopen 3 batch yug0804 the product was not returned for examination.The batch documentation was reviewed with focus on efficacy and delivery.No abnormalities relating to the observed problem were found.Nothing abnormal was found.
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