| Model Number MS9662 |
| Device Problem
Material Too Rigid or Stiff (1544)
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| Patient Problems
Cataract (1766); Hyperglycemia (1905); Hypoglycemia (1912); Pain (1994); Loss of Vision (2139); Complaint, Ill-Defined (2331); Coma (2417)
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| Event Date 07/31/2013 |
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Event Type
Injury
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Manufacturer Narrative
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If device is returned, evaluation will be performed to determine if a malfunction has occurred.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.
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Event Description
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(b)(4).This solicited case, reported by a consumer, with additional information from the initial consumer via a nutritionist from a patient support program (psp), concerns a female patient of unknown origin, born on (b)(6).Medical history was unknown.Concomitant medication included insulin glargine for an unknown indication.The patient received human insulin (rdna origin) nph (unknown manufacturer) and also human insulin (rdna origin) regular (unknown manufacturer); both unknown formulation, dose, frequency, indication for use and start date.It was unknown how human insulin nph and regular were delivered.On an unknown date, unknown time after beginning treatment with human insulin nph and regular, the patient had coma in two occasions (the first was two years after beginning of treatment and the second on an unknown date), and this event was considered serious by the company due to medically significant reasons.Information regarding corrective treatment and outcome for this event was not provided.On an unknown date, the patient discontinued treatment with human insulin nph and regular and started insulin lispro (humalog), 8iu five times a day (before breakfast, before lunch, at afternoon, before dinner and before sleep), subcutaneously, unknown indication for use and therapy start date.In 2012, unknown if prior discontinuing human insulin nph and regular or after beginning treatment with insulin lispro via humapen luxura burgundy (lot number 1401b08), the patient experienced cataract and her vision was 20% in the right eye and 50% in the left eye.It was also provided that the patient was trying to operate the eyes since 2013; however, she was unable due to unknown reason.Information regarding corrective treatment and outcome for this event was not provided.In (b)(6) 2013, unknown time after beginning treatment with insulin lispro, the patient was undergoing a blood exam and due to the fasting, the patient experienced a very severe hypoglycemia, which leaded to a coma.The events of hypoglycemic coma and hypoglycemia were considered serious by the company due to medically significant reasons.Information regarding corrective treatment and outcome for these events were not provided.It was also provided that the physician of the patient told her that if the glycaemia decreased too much, she could take a little amount of sugar or a candy in order to not break the fasting and to not let the insulin drop too much (as reported).Approximately in (b)(6) 2014 (reported as one week before (b)(6) 2014), unknown time after beginning treatment with insulin lispro, the patient experienced some intestinal problem, described as welling to use the bathroom all the time and, when defecating, releasing blood in stools.The patient had an appointment with a physician scheduled for (b)(6) 2014 due to these events.Moreover, on unknown dates, unknown time after beginning on lispro insulin, the patient's diabetes was uncontrolled and she experienced hypoglycemia during dawn and hyperglycemia in the afternoon.Also, since unknown date the patient experienced somnolence and pain on feet.Corrective treatment, laboratorial exam, outcome for the events were unknown.As of (b)(6) 2016, it was provided that the device plunger (which might be the injection screw) was stiff and did not want to go up (associated with (b)(4)).The patient never reused needles; always primed the pen before using and stored it at room temperature.The injections were performed in the belly, thigh and arm.Insulin lispro treatment was continued.The patient was the operator of the device and it was unknown if she was trained.It was unknown how long this device model was used and the reported device was used for less than two years.The return of the device was expected.The reporting nutritionist did not provide any opinion of relatedness.The reporting consumer stated that the events of hypoglycemia and hypoglycemic coma were not related to the insulin lispro but were more related to the fasting to do the exam.No other opinion of relatedness was provided by the reporting consumer.Update 07-oct-2014: additional information received from the initial reporter on 01-oct-2014 via a nutritionist from the psp was processed together with initial case entry.Edit 13-oct-2014: upon internal review on 13-oct-2013, corrected text on reporter description (via a nutritionist instead of that a nutritionist).Update 16aug2016: additional information received on 11aug2016 from initial reporting consumer.Updated initial reporter phone.Added patients date of birth; human insulin nph and regular as suspect drugs; humapen luxura burgundy as suspect device; insulin lispro treatment status, dose, frequency and route of administration; serious events of hypoglycemic coma; serious event of hypoglycemia and an serious event of coma; a non-serious event of cataract; treating physician information.Narrative and corresponding fields were updated accordingly.
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Manufacturer Narrative
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No further follow up is planned.Evaluation summary: a female patient reported historic events of hypoglycemia that were possibly related to fasting.She also reported that the "injection screw of her humapen luxura device was stiff and did not want to go up".The device was received by the affiliate; however, the device has not been received by the manufacturer for investigation (batch number 1401v08, manufactured january 2014).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the batch did not identify any atypical trends with regard to high injection force or dose accuracy.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.There is no evidence of improper use or storage.
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Event Description
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(b)(4).This solicited case, reported by a consumer, with additional information from the initial consumer via a nutritionist from a patient support program (psp), concerns a female patient of unknown origin, born on (b)(6) 1949.Medical history was unknown.Concomitant medication included insulin glargine for an unknown indication.The patient received human insulin (rdna origin) nph (unknown manufacturer) and also human insulin (rdna origin) regular (unknown manufacturer); both unknown formulation, dose, frequency, indication for use and start date.It was unknown how human insulin nph and regular were delivered.On an unknown date, unknown time after beginning treatment with human insulin nph and regular, the patient had coma in two occasions (the first was two years after beginning of treatment and the second on an unknown date), and this event was considered serious by the company due to medically significant reasons.Information regarding corrective treatment and outcome for this event was not provided.On an unknown date, the patient discontinued treatment with human insulin nph and regular and started insulin lispro (humalog), 8iu five times a day (before breakfast, before lunch, at afternoon, before dinner and before sleep), subcutaneously, unknown indication for use and therapy start date.In 2012, unknown if prior discontinuing human insulin nph and regular or after beginning treatment with insulin lispro via humapen luxura burgundy (lot number 1401b08), the patient experienced cataract and her vision was 20% in the right eye and 50% in the left eye.It was also provided that the patient was trying to operate the eyes since 2013; however, she was unable due to unknown reason.Information regarding corrective treatment and outcome for this event was not provided.In (b)(6) 2013, unknown time after beginning treatment with insulin lispro, the patient was undergoing a blood exam and due to the fasting, the patient experienced a very severe hypoglycemia, which leaded to a coma.The events of hypoglycemic coma and hypoglycemia were considered serious by the company due to medically significant reasons.Information regarding corrective treatment and outcome for these events were not provided.It was also provided that the physician of the patient told her that if the glycaemia decreased too much, she could take a little amount of sugar or a candy in order to not break the fasting and to not let the insulin drop too much (as reported).Approximately in (b)(6) 2014 (reported as one week before (b)(6) 2014), unknown time after beginning treatment with insulin lispro, the patient experienced some intestinal problem, described as welling to use the bathroom all the time and, when defecating, releasing blood in stools.The patient had an appointment with a physician scheduled for (b)(6) 2014 due to these events.Moreover, on unknown dates, unknown time after beginning on lispro insulin, the patient's diabetes was uncontrolled and she experienced hypoglycemia during dawn and hyperglycemia in the afternoon.Also, since unknown date the patient experienced somnolence and pain on feet.Corrective treatment, laboratorial exam, outcome for the events were unknown.As of (b)(6) 2016, it was provided that the device plunger (which might be the injection screw) was stiff and did not want to go up (associated with product complaint (b)(4)).The patient never reused needles; always primed the pen before using and stored it at room temperature.The injections were performed in the belly, thigh and arm.Insulin lispro treatment was continued.The patient was the operator of the device and it was unknown if she was trained.It was unknown how long this device model was used and the reported device was used for less than two years.The device was returned on 23-sep-2016.The reporting nutritionist did not provide any opinion of relatedness.The reporting consumer stated that the events of hypoglycemia and hypoglycemic coma were not related to the insulin lispro but were more related to the fasting to do the exam.No other opinion of relatedness was provided by the reporting consumer.Update 07-oct-2014: additional information received from the initial reporter on 01-oct-2014 via a nutritionist from the psp was processed together with initial case entry.Edit 13-oct-2014: upon internal review on 13-oct-2013, corrected text on reporter description (via a nutritionist instead of that a nutritionist).Update 16aug2016: additional information received on 11aug2016 from initial reporting consumer.Updated initial reporter phone.Added patients date of birth; human insulin nph and regular as suspect drugs; humapen luxura burgundy as suspect device; insulin lispro treatment status, dose, frequency and route of administration; serious events of hypoglycemic coma; serious event of hypoglycemia and an serious event of coma; a non-serious event of cataract; treating physician information.Narrative and corresponding fields were updated accordingly.Update 30-sep-2016: additional information received on 30-sep-2016 from the global product complaint database added the return date of the device.Update 04-oct-2016: additional information received on 04-oct-2016 from the global product complaint database added the device specific safety summary; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.
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Manufacturer Narrative
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Narrative field - new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 08nov2016 in the narrative field.No further follow up is planned.
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Event Description
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(b)(4).This solicited case, reported by a consumer, with additional information from the initial reporting consumer via a nutritionist from a patient support program (psp), concerns an adult female patient of unknown origin who was born on (b)(6).The medical history of patient was not provided.The concomitant medication included insulin glargine for an unknown indication.The patient received human insulin (rdna origin) nph (unknown manufacturer) and also human insulin (rdna origin) regular (unknown manufacturer); both of unknown formulation, dose, frequency and indication for use, beginning approximately in 1999.It was unknown how human insulin nph and regular were delivered.In 1999 or 2000, unknown time after beginning treatment with human insulin nph and regular, the patient had coma in two occasions because her blood glucose decreased very fast to 15 (no measure unit was provided) and this event was considered serious by the company due to life-threatening criteria.Information regarding corrective treatment and outcome for the hypoglycemic coma was not provided.At the time of first coma the endocrinologist decreased the human insulins doses but it did not resolve properly and it was provided that the problem was not the human insulins dosage but the peak (as reported).According to reporting consumer the patient lost her memory at the time of hypoglycemia, she became slow (as reported) and experienced the coma because there was nobody near to give her something sweet to eat.It was also provided that she lost her memory in several occasions at the time of hypoglycemia.Approximately in 2000 the physician decided to discontinue treatment with human insulin nph and regular due to the episodes of hypoglycemic coma and started insulin lispro (humalog), 8 iu five times a day (before breakfast, before lunch, at afternoon, before dinner and before sleep), subcutaneously, unknown indication for use and therapy start date.In 2012, unknown time after beginning treatment with insulin lispro via humapen luxura burgundy (lot number 1401b08), the patient experienced cataract and her vision was 20% in the right eye and 50% in the left eye.It was also provided on (b)(6) 2016 that the patient was trying to operate the eyes since 2013; however, she was unable due to unknown reason.Information regarding corrective treatment and outcome for this event was not provided.In (b)(6) 2013, approximately 13 years after beginning treatment with insulin lispro, the patient underwent a blood exam.After that she did not measure her glycemia, drank a coffee, administered one dose of insulin lispro and returned to sleep.At 10:30 a.M.She sat on a chair because she was slow (as reported) and waited her lunch getting heated by microwave oven but she passed out.It was provided she experienced a very severe hypoglycemia which leaded to a coma and she was sent to emergency center where she received saline solution and she recovered from coma at 06 p.M.The patient was not admitted to hospital at that time and this third event of hypoglycemic coma was considered serious by the company due to medically significant reasons.Information regarding corrective treatment and outcome for these events was not provided.It was also provided that the physician of the patient told her that if the glycemia decreased too much, she could take a little amount of sugar or a candy in order to not break the fasting and to not let the insulin drop too much (as reported).The reporting consumer stated that when the patient lost the memory, unknown if during treatment with human insulins or insulin lispro, her glycemic values were 25, 28 and 30 (no measure unit was provided) but sometimes people did not note she experienced this condition.According to reporting consumer on an unknown date the patient experienced the bad thing of hypoglycemia (as reported) in one occasion and she went out in order to eat something but she did not do it and started to walk.The patient did not realize she was doing, a known person talked to her but she did not recognize and was speaking things that did not make sense.The patient was fed at a bakery and she recovered from the hypoglycemia.In (b)(6) 2014 (reported as one week before (b)(6) 2014), approximately 14 years after beginning treatment with insulin lispro, the patient experienced some intestinal problem, described as welling to use the bathroom all the time and, when defecating, releasing blood in stools.The patient had an appointment with a physician scheduled for (b)(6) 2014 due to these events.Moreover, on unknown dates, unknown time after beginning lispro insulin therapy, the diabetes of patient was uncontrolled and she experienced hypoglycemia at dawn and hyperglycemia at afternoon.Also, since unknown date the patient experienced somnolence and pain on feet.Corrective treatment, exams, and outcome of these events were unknown.It was provided on (b)(6) 2016 that the device plunger (which might be the injection screw) was stiff and did not want to go up (associated with product (b)(4)).The patient never reused needles; she always primed the pen before using and stored it at room temperature.The injections were performed in the belly, thigh and arm.Insulin lispro treatment was continued.The patient was the operator of the device and it was unknown if she was trained.It was unknown how long this device model was used and the reported device was used for less than two years.The device was returned on 23sep2016, and no malfunction was found.The reporting nutritionist did not provide any opinion of relatedness.The reporting consumer stated that the first and second episode of hypoglycemic coma were related to the very strong peak (glycemia decreased very fast) caused by human insulin nph.The reporting consumer stated that the third event of hypoglycemic coma was not related to the insulin lispro but were more related to the fasting to undergo the exam.No other opinion of relatedness was provided by the reporting consumer.Update 07oct2014: additional information received from the initial reporter on 01oct2014 via a nutritionist from the psp was processed together with initial case entry.Edit 13oct2014: upon internal review on 13oct2013, corrected text on reporter description (via a nutritionist instead of that a nutritionist).Update 16aug2016: additional information received on 11aug2016 from initial reporting consumer.Updated initial reporter phone.Added patients date of birth; human insulin nph and regular as suspect drugs; humapen luxura burgundy as suspect device; insulin lispro treatment status, dose, frequency and route of administration; serious events of hypoglycemic coma; serious event of hypoglycemia and an serious event of coma; a non-serious event of cataract; treating physician information.Narrative and corresponding fields were updated accordingly.Update 30sep2016: additional information received on 30sep2016 from the global product complaint database added the return date of the device.Update 04oct2016: additional information received on 04oct2016 from the global product complaint database added the device specific safety summary; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.Update 24oct2016: additional information was received on 21oct2016 from initial reporting consumer.Added adult as age group of patient; added start date of human insulins and insulin lispro; added patient experienced coma in two occasions during treatment with human insulins due to decreased glycemia and updated coding accordingly; updated serious criteria of hypoglycemic coma (blood glucose of 15) to life-threatening; added reason human insulin nph and human insulin regular were replaced by insulin lispro; added patient lost memory at the time of hypoglycemia and she became slow; added patient received saline solution at emergency center as corrective treatment for the third episode of hypoglycemic coma and she was recovered from this event; added at that time of one hypoglycemic episode the patient went out in order to eat something but she did not do it and started to walk, she did not realize she was doing, a known person talked to her but she did not recognize and was speaking things that did not make sense; added relatedness opinion between human insulin nph and the first and second episodes of hypoglycemia coma.Corresponding fields and narrative updated accordingly.Update 08nov2016: additional information received on 08nov2016 from the global product complaint database added the device specific safety summary; updated the malfunction field to no; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.
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Search Alerts/Recalls
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