Model Number MS9673A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Cataract (1766); Hearing Impairment (1881); Hyperglycemia (1905); Hypoglycemia (1912); Blurred Vision (2137); Coma (2417)
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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 spontaneous case, reported by a consumer, who contact the company to report and product complaint and an adverse event, concerns a female patient of unknown origin, (b)(6).Medical history included rheumatism since she was (b)(6), strong pain on the knee and crooked toes due to rheumatism and because of that, she wore wheelchair.Concomitant medication included many unspecified medications.The patient received human insulin (rdna) nph (humulin n), 22 iu in the morning, 14 iu in the afternoon and human insulin (rdna) regular (humulin r), 6 iu in the morning and 4 iu in the afternoon, both daily, subcutaneously, indicated for diabetes.It was provided the patient receiving the human insulin nph and regular via humapen luxura hd and humapen savvio.Since an unspecified date, unknown time to onset, the patient had been experiencing difficulty hearing.As a corrective measure, the patient wore a hearing aid device, but did not recover of the event.Also, the reporting consumer stated the patient an unspecified heart problem, which the patient did not know what it was.The patient received an unspecified medication for heart problem.Additionally, the initial reporter consumer stated the patient had already entered in coma five times, due to lack of food, since the patient did not eat overnight and her glycaemia dropped down.When that happened a help mobile went to the patient s home and administered glucose into her vein and she was recovered.It was unclear if the patient had used both devices during coma.On an unspecified date, unknown time to onset, the patient experienced cataract.As corrective treatment in 2011, she underwent to a surgery and recovered of cataract and could see very well.The events of coma and cataract were considered serious and medically significant by the company.Nevertheless, it was provided that occasionally the patient experienced blurred vision due to diabetes, when her glycaemia was high; usually around 200, 300 never lower than 150 (units and range not provided).The patient did not receive any corrective treatment for blurred vision and did not recover of it.It was unknown if the patient received any corrective treatment for glycaemia was high and the outcome was not provided.Also, since unspecified date reported as lately, the patient was forgetting things.The reporter consumer stated that according to her physician, the patient was forgetting things because of a vein on the neck that was clogged.Due to that on (b)(6) 2016, she underwent to an unspecified surgical procedure to unclog this vein.The outcome was not provided.The event of patient was forgetting this was considered serious and medically significant by the company.Furthermore, on unspecified date the patient noticed the humapen luxura hd, batch number (b)(4) and humapen savvio 1403v04 were not working, because it was jammed and the insulin was not coming out.No adverse event was reported due to the device problem.The patient did not reuse needles and stored the pen at room temperature.The treatment with human insulin nph and regular were continued.This humapen savvio is associated with (b)(4) and humapen luxura hd (b)(4).The patient operated the devices and she was a trained user.It was provided that both devices were new and had been used for a short time.Humapen savvio 1403v04 will not return.Usage concerns resolved and device was reported to be working properly.Humapen luxura hd will return.If device is returned, evaluation will be performed to determine if a malfunction has occurred.The reporting consumer related the events of cataract, blurred vision; glycaemia was high, difficulty hearing, heart problem, and coma to human insulin nph and regular treatment.No other relatedness opinion was provided.(b)(4).Update 07apr2016: upon review, this case was opened to complete the medwatch fields for regulatory reporting.Edit 12apr2016: case unlocked to add product complaint number only.
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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 statement dated 19apr2016.There were 2 devices implicated this is associated with lot 1210g01.Evaluation summary a female patient reported her humapen luxura hd device was jammed and insulin would not come out.She experienced a serious adverse event of hypoglycemic coma and a nonserious adverse event of increased blood glucose, although neither event was related to the complaint.The device was not returned for investigation (batch (b)(4), manufactured october 2012).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of this batch did not identify any atypical trends with regard to pen jammed and dose accuracy.All humapen luxura hd devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy.There is no evidence of improper use or storage.
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Event Description
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(b)(4).This spontaneous case, reported by a consumer, who contact the company to report and product complaint and an adverse event, concerns a female patient of unknown origin, (b)(6).Medical history included rheumatism since she was (b)(6), strong pain on the knee and crooked toes due to rheumatism and because of that, she wore wheelchair.Concomitant medication included many unspecified medications.The patient received human insulin (rdna) nph (humulin n), 22 iu in the morning, 14 iu in the afternoon and human insulin (rdna) regular (humulin r), 6 iu in the morning and 4 iu in the afternoon, both daily, subcutaneously, indicated for diabetes.It was provided the patient receiving the human insulin nph and regular via humapen luxura hd and humapen savvio.Since an unspecified date, unknown time to onset, the patient had been experiencing difficulty hearing.As a corrective measure, the patient wore a hearing aid device, but did not recover of the event.Also, the reporting consumer stated the patient an unspecified heart problem, which the patient did not know what it was.The patient received an unspecified medication for heart problem.Additionally, the initial reporter consumer stated the patient had already entered in coma five times, due to lack of food, since the patient did not eat overnight and her glycaemia dropped down.When that happened a help mobile went to the patient s home and administered glucose into her vein and she was recovered.It was unclear if the patient had used both devices during coma.On an unspecified date, unknown time to onset, the patient experienced cataract.As corrective treatment in 2011, she underwent to a surgery and recovered of cataract and could see very well.The events of coma and cataract were considered serious and medically significant by the company.Nevertheless, it was provided that occasionally the patient experienced blurred vision due to diabetes, when her glycaemia was high; usually around 200, 300 never lower than 150 (units and range not provided).The patient did not receive any corrective treatment for blurred vision and did not recover of it.It was unknown if the patient received any corrective treatment for glycaemia was high and the outcome was not provided.Also, since unspecified date reported as lately, the patient was forgetting things.The reporter consumer stated that according to her physician, the patient was forgetting things because of a vein on the neck that was clogged.Due to that on (b)(6) 2016, she underwent to an unspecified surgical procedure to unclog this vein.The outcome was not provided.The event of patient was forgetting this was considered serious and medically significant by the company.Furthermore, on unspecified date the patient noticed the humapen luxura hd, batch number ((b)(4)) and humapen savvio ((b)(4)) were not working, because it was jammed and the insulin was not coming out.No adverse event was reported due to the device problem.The patient did not reuse needles and stored the pen at room temperature.The treatment with human insulin nph and regular were continued.The patient operated the devices and she was a trained user.It was provided that both devices were new and had been used for a short time.Humapen savvio 1403v04 will not return.Usage concerns resolved and device was reported to be working properly.Humapen luxura hd was not returned therefore an evaluation was not possible.The reporting consumer related the events of cataract, blurred vision; glycaemia was high, difficulty hearing, heart problem, and coma to human insulin nph and regular treatment.No other relatedness opinion was provided.(b)(4).Update 07apr2016: upon review, this case was opened to complete the medwatch fields for regulatory reporting.Edit 12apr2016: case unlocked to add product complaint number only.Update 19apr2016.Additional information received 18apr2016 from the product complaint safety database.To the device tabs added manufacture dates, the device specific safety summaries (dsss), updated the european and canadian (eu/ca) device information, updated the medwatch device information, and the narrative was updated accordingly.
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Search Alerts/Recalls
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