Model Number MS9673A |
Device Problems
Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339)
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Patient Problem
Hypoglycemia (1912)
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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 pharmacist who contacted the company to report an adverse event and a product complaint (pc), concerned a (b)(6) female patient of unknown origin.Medical history and concomitant medications were not reported.The patient received human insulin (rdna origin) injections (humulin r) through an unknown formulation via reusable pens (humapen luxura hd) and humapen luxura, 4-10 iu subcutaneously for the treatment of type two diabetes.Start date and frequency were not reported.She also received human insulin isophane suspension (rdna origin) injections (humulin nph) through an unknown formulation via a reusable pen (humapen luxura hd) and humapen luxura subcutaneously for the treatment of type two diabetes.Dose, frequency and start date were not reported.On an unspecified date while on human insulin and human insulin isophane suspension she developed life-threatening hypoglycaemia because her humapen luxura hd was injecting double dosage, so she injected too much insulin.Information regarding outcome of the events, corrective treatment and human insulin and human insulin isophane suspension treatment status was not provided.The patient was the operator of the humapen luxura hd and her training status was unknown.The general humapen luxura hd duration of use was not reported.The suspect humapen luxura hd duration of use was of approximately six weeks.The action taken with the device was unknown.The reporting pharmacist did not provide an assessment of relatedness between the events and human insulin, human insulin isophane suspension or the humapen luxura hd.No follow-up would be requested since the reporter refused to provide more information.Treating physician contact details not provided.Update 15aug2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.
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Manufacturer Narrative
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(b)(4).No further follow up is planned.
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Event Description
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Lilly case id: (b)(4).This spontaneous case, reported by a pharmacist who contacted the company to report an adverse event and a product complaint (pc), concerned a (b)(6) female patient of unknown origin.Medical history and concomitant medications were not reported.The patient received human insulin (rdna origin) injections (huminsulin r) through an unknown formulation via reusable pens (humapen luxura hd) and humapen luxura, 4-10 iu subcutaneously for the treatment of type two diabetes.Start date and frequency were not reported.She also received human insulin isophane suspension (rdna origin) injections (huminsulin nph) through an unknown formulation via a reusable pen (humapen luxura hd) and humapen luxura subcutaneously for the treatment of type two diabetes.Dose, frequency and start date were not reported.On an unspecified date while on human insulin and human insulin isophane suspension she developed life-threatening hypoglycaemia because her humapen luxura hd was injecting double dosage, so she injected too much insulin.Information regarding outcome of the events, corrective treatment and human insulin and human insulin isophane suspension treatment status was not provided.The patient was the operator of the humapen luxura hd and her training status was unknown.The general humapen luxura hd duration of use was not reported.The suspect humapen luxura hd duration of use was of approximately six weeks.The device was returned on 16sep2016, and no malfunction was found.The reporting pharmacist did not provide an assessment of relatedness between the events and human insulin, human insulin isophane suspension or the humapen luxura hd.No follow-up would be requested since the reporter refused to provide more information.Treating physician contact details not provided.Update 15aug2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.Update 08nov2016: additional information received on 08nov2016 from the global product complaint database added the device specific safety summary, the manufactured date of the device, and return date of the device; updated the malfunction field to no; updated the medwatch and european and (b)(4) required device reporting elements; and updated the narrative.
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Search Alerts/Recalls
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