| Model Number MS9663 |
| Device Problems
Break (1069); Leak/Splash (1354); Loose or Intermittent Connection (1371); Inaccurate Delivery (2339)
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| Patient Problems
Hyperglycemia (1905); Coma (2417); No Code Available (3191)
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| Event Date 01/31/2014 |
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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, regarding a patient who took part of a patient support program (psp), with additional information from a second consumer, concerns an elderly brown female patient who was born on (b)(6).The medical history of the patient was not provided.Historical drug included human insulin for unknown indication for use.The concomitant medications included diosmin for circulation; carvedilol for the heart (as reported); cholecalciferol for anemia; metformin, losartan, rosuvastatin calcium, hydrochlorothiazide, acetylsalicylic acid, insulin degludec, unspecified medication reported as trezon, metformin hydrochloride and trimetazidine hydrochloride, all of them for unknown indications.The patient received insulin lispro (humalog) cartridge, subcutaneously (only in the abdomen), unknown dose, frequency and indication for use, beginning on an unspecified date in 2010.On an unspecified date, unknown if after or prior to the starting of insulin lispro, the patient experienced cardiac problems and did not see very well.Information regarding exams, corrective treatment and outcome for cardiac problems and did not see very well was not provided.On an unspecified date in 2014, unknown exact time after beginning lispro insulin via humapen luxura champagne, the patient stayed hospitalized for ten days in order to undergo a surgery for stent placement as because she felt unwell and progressed to diabetic coma.According to reporting consumer the patient did not receive insulin lispro for an unspecified period at the time of hospitalization.Information regarding exams and outcome of these events was not provided.It was provided that humapen luxura champagne (lot number 0907b03) was not measuring the glucose correctly (as reported).According to the reporting consumer the cap of humapen luxura champagne had been damaged and the silver trim ring had broken.The patient had tightened the cartridge holder at the device body because it was loose, when, she suddenly broke the silver trim ring and due to it, the device was leaking (pc number 3549042).It was also provided the patient thought she was not injecting correct dose of lispro insulin because the humapen luxura champagne was not releasing the selected dose, and due to it she experienced high glycemia (also reported as uncontrolled glycemia).It was also provided that the glycemia of the patient did not have a parameter because it was high and low (as reported), also described as unbalanced glycemia.The patient did not receive corrective treatment for high glycemia and blood glucose fluctuation and it was not provided if she received corrective treatment for the incorrect dose administered.The patient recovered from high glycemia on an unknown date and it was unknown if she was recovered from the incorrect dose administered and blood glucose fluctuation.It was provided the patient stored the humapen luxura champagne in the refrigerator.On an unspecified date in 2016 the patient started to use humapen savvio (graphite) in order to deliver insulin lispro.On (b)(6) 2016, approximately six years after the starting of insulin lispro, the patient felt unwell because she did not receive insulin lispro due to unknown reason.Information regarding exams, corrective treatment and outcome of feeling unwell and drug dose omission was not provided.As of (b)(6) 2016 the patient was using syringe in order to deliver insulin lispro because the humapen savvio (graphite) (lot 1404v11) was not releasing it.On (b)(6) 2016, the patients glycemia was 309 (unknown units and reference range) in the morning, 354 before lunch and 351 before dinner, getting in the same level as when she did not receive the insulin.The corrective treatment and the outcome for the event of high glucose was not provided.Troubleshooting was performed three times and two attempts were successfully.On an unspecified date in 2016, the patient started using another humapen savvio graphite (unknown lot) in order to deliver insulin lispro, but the pen was also faulty and did not release the insulin.In addition, it was reported the insulin lispro was not having effect because her glucose did not decrease.Information about the corrective treatment, laboratorial exams and the outcome for glucose did not decrease was not provided.As of (b)(6) 2016, the patient was with bad head, also reported as confused mind due to diabetic coma.The corrective treatment, exams and the outcome for mental disorder was not provided.Treatment with insulin lispro was continued.The patient operated the device and she was trained by a company representative.The patient had used the device model humapen luxura champagne and the reported device for about six years.The patient used the device model humapen savvio graphite since 2016 and the reported device for unknown time.Both devices were available to return to manufacturer.If device is returned, evaluation will be performed.The first reporting consumer did not know if the first event of blood glucose increased was related to lispro insulin, related the lack of drug effect to insulin lispro, related the event of mental disorder to diabetic coma and did not provide a relatedness opinion for the remaining events.The first reporting consumer stated the first event of blood glucose increased and incorrect dose administered occurred due to the problem of humapen luxura champagne and related the second event of drug dose omission to faulty of humapen savvio graphite.The second reporting consumer stated that the event of blood glucose fluctuation was possibly related to insulin lispro and did not provide a relatedness opinion between insulin lispro and the remaining events.Update 26jan2016: additional information was received on 20jan2016 and 21jan2016 from initial reporting consumer and on 21jan2016 from a second reporting consumer.Added second consumer as reporter; added cholecalciferol, metformin hydrochloride and trimetazidine hydrochloride as concomitant medications; added the non-serious events of visual impairment, drug dose omission and feeling unwell; updated to hospitalization the serious criteria of malaise and coma; added yes as relatedness opinion of second consumer regarding the event of blood glucose fluctuation; added humapen savvio (graphite) as concomitant device.Corresponding fields and narrative updated accordingly.Update 11feb2016: additional information received on 04feb2016 from the initial reporter.Added the non-serious events of glucose high and bad head.Added the lot number of humapen savvio (graphite).Updated narrative and fields with new information accordingly.Update 22feb2016: additional information received on 17feb2016 from the initial consumer reporter.Added humapen savvio graphite as suspect product.Added the patient experienced a diabetic coma, so the coding of this event was updated from coma to diabetic coma.Added the non-serious events of cardiac problems, drug dose omission, lack of drug effect and blood glucose increased.Updated the description as reported for the event of mental disorder.Updated the as reported causality of humapen luxura champagne for the serious event of diabetic coma to device nhcp.Correspondent fields and narrative were updated accordingly.Update 23feb2016: upon review, the case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting.
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Manufacturer Narrative
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Evaluation summary: a female patient reported that her humapen luxura wasn't dosing insulin well.The patient stated that she "had tightened the cartridge holder at the pen body because it was loose, when she suddenly broke the silver trim ring.Because of that, the device is now leaking." she did not know if she was receiving the correct dose of insulin.She experienced increased blood glucose levels and fluctuations.Investigation of the returned device (batch (b)(4), manufactured july 2009) found a detached trim ring and foreign material present on the device cap, front housing threads, and pen body.No leaking was observed when dialing or injecting a dose.The device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The user manual instructs to not use the device if it appears broken or damaged and to contact lilly or your healthcare professional for a replacement pen.The patient also stores the device in the refrigerator.The device user manual instructs not to store the device in a refrigerator.There is evidence of improper use and storage.The patient reported breaking the cartridge holder while in the field.However, the broken trim ring did not affect functionality of the pen and may not be relevant to the complaint of increased blood glucose levels and fluctuations.Foreign material present on the device occurred while in the field (not related to the manufacturing process.The patient stores the device in a refrigerator.This may be relevant to the complaint of leaking.
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Event Description
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(b)(4).This solicited case reported by a consumer, regarding a patient who took part of a patient support program (psp), with additional information from a second consumer, concerns an elderly (b)(6) female patient who was born on (b)(6).The medical history of the patient was not provided.Historical drug included human insulin for unknown indication for use.The concomitant medications included diosmin for circulation; carvedilol for the heart (as reported); cholecalciferol for anemia; metformin, losartan, rosuvastatin calcium, hydrochlorothiazide, acetylsalicylic acid, insulin degludec, unspecified medication reported as trezon, metformin hydrochloride and trimetazidine hydrochloride, all of them for unknown indications.The patient received insulin lispro (humalog) cartridge, subcutaneously (only in the abdomen), unknown dose, frequency and indication for use, beginning on an unspecified date in 2010.On an unspecified date, unknown if after or prior to the starting of insulin lispro, the patient experienced cardiac problems and did not see very well.Information regarding exams, corrective treatment and outcome for cardiac problems and did not see very well was not provided.On an unspecified date in 2014, unknown exact time after beginning lispro insulin via humapen luxura champagne, the patient stayed hospitalized for ten days in order to undergo a surgery for stent placement as because she felt unwell and progressed to diabetic coma.According to reporting consumer the patient did not receive insulin lispro for an unspecified period at the time of hospitalization.Information regarding exams and outcome of these events was not provided.It was provided that humapen luxura champagne (lot number 0907b03/associated pc) was not measuring the glucose correctly (as reported).According to the reporting consumer the cap of humapen luxura champagne had been damaged and the silver trim ring had broken.The patient had tightened the cartridge holder at the device body because it was loose, when, she suddenly broke the silver trim ring and due to it, the device was leaking ((b)(4)).It was also provided the patient thought she was not injecting correct dose of lispro insulin because the humapen luxura champagne was not releasing the selected dose, and due to it she experienced high glycemia (also reported as uncontrolled glycemia).It was also provided that the glycemia of the patient did not have a parameter because it was high and low (as reported), also described as unbalanced glycemia.The patient did not receive corrective treatment for high glycemia and blood glucose fluctuation and it was not provided if she received corrective treatment for the incorrect dose administered.The patient recovered from high glycemia on an unknown date and it was unknown if she was recovered from the incorrect dose administered and blood glucose fluctuation.It was provided the patient stored the humapen luxura champagne in the refrigerator.On an unspecified date in 2016 the patient started to use humapen savvio (graphite) in order to deliver insulin lispro.On (b)(6) 2016, approximately six years after the starting of insulin lispro, the patient felt unwell because she did not receive insulin lispro due to unknown reason.Information regarding exams, corrective treatment and outcome of feeling unwell and drug dose omission was not provided.As of 20jan2016 the patient was using syringe in order to deliver insulin lispro because the humapen savvio (graphite) (lot 1404v11) was not releasing it.On (b)(6) 2016, the patients glycemia was 309 (unknown units and reference range) in the morning, 354 before lunch and 351 before dinner, getting in the same level as when she did not receive the insulin.The corrective treatment and the outcome for the event of high glucose was not provided.Troubleshooting was performed three times and two attempts were successfully.On an unspecified date in 2016, the patient started using another humapen savvio graphite (unknown lot) in order to deliver insulin lispro, but the pen was also faulty and did not release the insulin.In addition, it was reported the insulin lispro was not having effect because her glucose did not decrease.Information about the corrective treatment, laboratorial exams and the outcome for glucose did not decrease was not provided.As of 04feb2016, the patient was with bad head, also reported as confused mind due to diabetic coma.The corrective treatment, exams and the outcome for mental disorder was not provided.Furthermore, since approximately the week of (b)(6) 2016, the patient had been experiencing flu.As corrective treatment, she was receiving paracetamol 750 mg.As of 01mar2016, the outcome of flu was unknown.Treatment with insulin lispro was continued.The patient operated the device and she was trained by a company representative.The patient had used the device model humapen luxura champagne and the reported device for about six years.The patient used the device model humapen savvio graphite since 2016 and the reported device for unknown time.Both devices were available to return to manufacturer.If humapen savvio graphite is returned, evaluation will be performed.The humapen luxura champagne returned to manufacturer on 10mar2016, no malfunction was found.The first reporting consumer did not know if the first event of blood glucose increased was related to lispro insulin, related the lack of drug effect to insulin lispro, related the event of mental disorder to diabetic coma and did not provide a relatedness opinion for the remaining events.The first reporting consumer stated the first event of blood glucose increased and incorrect dose administered occurred due to the problem of humapen luxura champagne and related the second event of drug dose omission to faulty of humapen savvio graphite.The second reporting consumer stated that the event of blood glucose fluctuation was possibly related to insulin lispro and did not provide a relatedness opinion between insulin lispro and the remaining events.No relatedness opinion was provided between the event of flu and insulin lispro.Update 26jan2016: additional information was received on 20jan2016 and 21jan2016 from initial reporting consumer and on 21jan2016 from a second reporting consumer.Added second consumer as reporter; added cholecalciferol, metformin hydrochloride and trimetazidine hydrochloride as concomitant medications; added the non-serious events of visual impairment, drug dose omission and feeling unwell; updated to hospitalization the serious criteria of malaise and coma; added yes as relatedness opinion of second consumer regarding the event of blood glucose fluctuation; added humapen savvio (graphite) as concomitant device.Corresponding fields and narrative updated accordingly.Update 11feb2016: additional information received on 04feb2016 from the initial reporter.Added the non-serious events of glucose high and bad head.Added the lot number of humapen savvio (graphite).Updated narrative and fields with new information accordingly.Update 22feb2016: additional information received on 17feb2016 from the initial consumer reporter.Added humapen savvio graphite as suspect product.Added the patient experienced a diabetic coma, so the coding of this event was updated from coma to diabetic coma.Added the non-serious events of cardiac problems, drug dose omission, lack of drug effect and blood glucose increased.Updated the description as reported for the event of mental disorder.Updated the as reported causality of humapen luxura champagne for the serious event of diabetic coma to device nhcp.Correspondent fields and narrative were updated accordingly.Update 23feb2016: upon review, the case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting.Update 03mar2016: additional information received on 01mar2016 from the initial reporter consumer.Added a non-serious event of flu and corrective treatment.Updated causality opinion.Updated narrative and fields with new information accordingly.Update 12apr2016.Additional information received 12apr2016 from the product complaint safety database.To the humapen luxura champagne device tab changed malfunction to no, added manufacture date, the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, entered the medwatch device information, and the narrative was updated accordingly.
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Search Alerts/Recalls
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