Model Number MS9557 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hyperglycemia (1905); Blurred Vision (2137); Weight Changes (2607)
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Event Type
Injury
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Manufacturer Narrative
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There was no reported complaint for this device and its return is not expected.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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Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a (b)(6) female patient of han origin.Medical history included that three sisters got diabetes and concomitant medications included acarbose for type ii diabetes.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog 50, 300 units/3 ml) cartridge via reusable humapen ergo ii (blue) pen, 18 units in morning, 16 units at night, subcutaneously for the treatment of type ii diabetes, beginning approximately on 2014 or 2015.Since 2014 or 2015, possibly after starting the insulin lispro protamine suspension 50%/insulin lispro 50% treatment, she experienced that her eyes could not see clearly.She experienced high and unstable blood sugar (no values provided), due to which on (b)(6) 2018, she was hospitalized.After hospitalization, the insulin lispro protamine suspension 50%/insulin lispro 50% treatment was discontinued.The humapen ergo ii was also stopped on an unknown date.((b)(4); lot number unknown).She was adjusted to insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog 25, 300 units/3 ml) cartridge, 18-20 units in morning, 14-16 units at night, subcutaneously for the treatment of type ii diabetes, beginning on (b)(6) 2018.The dosage was adjusted according to blood sugar level by medical advice.After insulin lispro protamine suspension 75%/insulin lispro 25%, she experienced high blood sugar (no values provided) and she did not paid attention to diet.Approximately on (b)(6) 2018 or (b)(6) 2018, she got fat and her weight increased (no values provided).On an unknown date, her eyes had blurred.Since an unknown date while on treatment (unspecified if while on insulin lispro protamine suspension 50%/insulin lispro 50% or insulin lispro protamine suspension 75%/insulin lispro 25% treatment), she missed the injection of insulin sometimes.She was not recovered from the events of weight increased, visual impairment and blurred eyes.And the outcome of the remaining events was not provided.No information regarding corrective treatment was provided.Insulin lispro protamine suspension 75%/insulin lispro 25% treatment was continued.The operator of the humapen ergo ii and training status was unknown.The humapen ergo ii model duration of use and the suspect humapen ergo ii duration of use were not provided.The action taken with the suspect humapen ergo ii and its return status were not provided.The reporting consumer did not provide the relatedness of the events with insulin lispro protamine suspension 50%/insulin lispro 50% treatment or humapen ergo ii.The initial reporter did not known if the events of blurred eyes, visual impairment and weight increased were related to insulin lispro protamine suspension 75%/insulin lispro 25% treatment and did not provide an assessment of relatedness between the blood glucose increased and insulin lispro protamine suspension 75%/insulin lispro 25% treatment.The reporting consumer related high blood sugar and unstable blood sugar was related with diet.The reporting consumer did not know if the missed dose event was related to insulin lispro protamine suspension 50%/insulin lispro 50% or insulin lispro protamine suspension 75%/insulin lispro 25% treatment.Update (b)(6) 2018: additional information received on (b)(6) 2018, from the initial reporter via psp.Added one non-serious event of blurred eyes.Updated the event verbatim and outcome from unknown to not recovered for the events of visual impairment and weight increased.Updated the causality from not reported to unknown for the event of weight increased.Updated the causality statement and narrative with new information.Update 01-nov-2018: information was received on (b)(6) 2018 from rcp regarding (b)(4).The same was processed in catool and updated in narrative accordingly.No new medically significant information was received and no further changes were done to the case.Update 06-nov-2018: additional information was received on (b)(6) 2018 from the reporting consumer via psp.Added the non-serious event of missed dose.Updated insulin lispro protamine suspension 75%/insulin lispro 25% status.Updated narrative accordingly.Edit 08nov2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.
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Event Description
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Lilly case id: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a 46-year old female patient of han origin.Medical history included that three sisters got diabetes and concomitant medications included acarbose for type ii diabetes.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog 50, 300 units/3 ml) cartridge via reusable humapen ergo ii (blue) pen, 18 units in morning, 16 units at night, subcutaneously for the treatment of type ii diabetes, beginning approximately on 2014 or 2015.Since 2014 or 2015, possibly after starting the insulin lispro protamine suspension 50%/insulin lispro 50% treatment, she experienced that her eyes could not see clearly.It was noted that the injection button of a humapen ergo ii could not be pushed down (product complaint: (b)(4), lot number: unknown).She experienced high and unstable blood sugar (no values provided), due to which on mar-2018, she was hospitalized.After hospitalization, the insulin lispro protamine suspension 50%/insulin lispro 50% treatment was discontinued.The humapen ergo ii was also stopped on an unknown date.She was adjusted to insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog 25, 300 units/3 ml) cartridge, 18-20 units in morning, 14-16 units at night, subcutaneously for the treatment of type ii diabetes, beginning on mar-2018.The dosage was adjusted according to blood sugar level by medical advice.After insulin lispro protamine suspension 75%/insulin lispro 25%, she experienced high blood sugar (no values provided) and she did not paid attention to diet.Approximately on aug-2018 or sep-2018, she got fat and her weight increased (no values provided).On an unknown date, her eyes had blurred.Since an unknown date while on treatment (unspecified if while on insulin lispro protamine suspension 50%/insulin lispro 50% or insulin lispro protamine suspension 75%/insulin lispro 25% treatment), she missed the injection of insulin sometimes.She was not recovered from the events of weight increased, visual impairment and blurred eyes.And the outcome of the remaining events was not provided.No information regarding corrective treatment was provided.Insulin lispro protamine suspension 75%/insulin lispro 25% treatment was continued.The operator of the humapen ergo ii and training status was unknown.The humapen ergo ii model duration of use and the suspect humapen ergo ii duration of use were not provided.The suspect humapen ergo ii device associated with product complaint: (b)(4) was not returned to the manufacturer.The reporting consumer did not provide the relatedness of the events with insulin lispro protamine suspension 50%/insulin lispro 50% treatment or humapen ergo ii.The initial reporter did not known if the events of blurred eyes, visual impairment and weight increased were related to insulin lispro protamine suspension 75%/insulin lispro 25% treatment and did not provide an assessment of relatedness between the blood glucose increased and insulin lispro protamine suspension 75%/insulin lispro 25% treatment.The reporting consumer related high blood sugar and unstable blood sugar was related with diet.The reporting consumer did not know if the missed dose event was related to insulin lispro protamine suspension 50%/insulin lispro 50% or insulin lispro protamine suspension 75%/insulin lispro 25% treatment.Update 31-oct-2018: additional information received on 26-oct-2018, from the initial reporter via psp.Added one non-serious event of blurred eyes.Updated the event verbatim and outcome from unknown to not recovered for the events of visual impairment and weight increased.Updated the causality from not reported to unknown for the event of weight increased.Updated the causality statement and narrative with new information.Update 01-nov-2018: information was received on 29-oct-2018 from rcp regarding pc number: (b)(4).The same was processed in catool and updated in narrative accordingly.No new medically significant information was received and no further changes were done to the case.Update 06-nov-2018: additional information was received on 26-oct-2018 from the reporting consumer via psp.Added the non-serious event of missed dose.Updated insulin lispro protamine suspension 75%/insulin lispro 25% status.Updated narrative accordingly.Edit 08nov2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 27nov2018: additional information received on 26nov2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information, improper use and storage from no to yes, and malfunction from unknown to no.Noted the humapen ergo ii device associated with product complaint: (b)(4) was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.
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Manufacturer Narrative
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No further follow-up is planned.Event narrative field: new, updated and corrected information is referenced within the update statements in event.Please refer to update statement dated 27nov2018 in the event field.Evaluation summary: a female patient reported that the injection button of her humapen ergo ii device could not be pushed down.She experienced increased blood glucose.The device was not returned for investigation (batch unknown).The pen was checked by a diabetes educator, and it was determined the needle was the issue and the pen was working normally.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.The patient also reported she could not see clearly.The core user manual states the humapen ergo ii device is not recommended for the blind or the visually impaired without the assistance of a sighted individual trained to use it.There is evidence of improper use.The patient used the device while visually impaired.It is unknown if this is relevant to the event of increased blood glucose.
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Search Alerts/Recalls
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