Model Number UNKNOWN |
Device Problems
Failure to Deliver (2338); Physical Resistance/Sticking (4012)
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Patient Problems
Hyperglycemia (1905); 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.This report is associated with 1819470-2019-00174 and 1819470-2019-00175 since there is more than one device implicated.
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Event Description
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(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6)-year-old female patient of unknown origin.Medical history was not provided.Concomitant medications included unspecified hypertension medications and unspecified medications for thyroid disease.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injection (humulin 70/30), unknown formulation via a reusable device humapen ergo unknown body type, subcutaneously, for the treatment of diabetes mellitus, beginning approximately in 2015 or 2016.On an unknown date, 5-6 months after using humapen ergo unknown body type, it was not able to release insulin as its screw got stuck and possibly missed the dose and had hyperglycemic coma (pc pending/lot unknown).Since an unknown date, she started receiving human insulin isophane suspension 70%/human insulin 30% treatment via a humapen savvio pink which was spoiled in the same way after few months, and possibly had missed the dose due to pen issue and had hyperglycemic coma ((b)(4)/lot unknown).Approximately on (b)(6) 2019, she took human insulin isophane suspension 70%/human insulin 30% treatment via a humapen ergo unknown body type which was spoiled in the same way after one time use (one dose) and possibly had missed the dose due to pen issue and had hyperglycemic coma ((b)(4)/lot unknown).The event of hyperglycemic coma was considered as serious due to its medical significance.She had recovered from the events.Corrective treatment was not provided.As of (b)(6) 2019, treatment with human insulin isophane suspension 70%/human insulin 30% was continued.The operator of humapen ergo unknown body type (both devices) and humapen savvio pink and his/her training status was not provided.The general model humapen ergo unknown body type (both devices) and humapen savvio pink duration of use was not provided.The suspect humapen ergo unknown body type (first device) duration of use was approximately six months as started approximately in 2015 or 2016.The suspect humapen ergo unknown body type (second device) was one day and humapen savvio pink duration of use was not provided.The status of humapen ergo unknown body type (both devices) and humapen savvio pink was discontinued and their return was expected.The initial reporting consumer did not relate the events with human insulin isophane suspension 70%/human insulin 30% treatment.The initial reporting consumer related the events with product complaint associated with humapen ergo unknown body type (both devices) and humapen savvio pink.Update 13-sep-2019: all the documents received on 09-sep-2019 were processed at same time.Edit 25sep2019: updated medwatch fields for expedited device reporting.No new information added.Edit 02oct2019: updated medwatch fields for expedited device reporting.No new information added.Edit 02oct2019: updated medwatch 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 a patient support program (psp), concerned a 46-year-old female patient of unknown origin.Medical history was not provided.Concomitant medications included unspecified hypertension medications and unspecified medications for thyroid disease.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injection (humulin 70/30), unknown formulation via a reusable device humapen ergo unknown body type, subcutaneously, for the treatment of diabetes mellitus, beginning approximately in 2015 or 2016.On an unknown date, 5-6 months after using humapen ergo unknown body type, it was not able to release insulin as its screw got stuck and possibly missed the dose and had hyperglycemic coma (product complaint (b)(4)/lot unknown).Since an unknown date, she started receiving human insulin isophane suspension 70%/human insulin 30% treatment via a humapen savvio pink which was spoiled in the same way after few months, and possibly had missed the dose due to pen issue and had hyperglycemic coma (product complaint 4878532/lot unknown).Approximately on (b)(6) 2019, she took human insulin isophane suspension 70%/human insulin 30% treatment via a humapen ergo unknown body type which was spoiled in the same way after one time use (one dose) and possibly had missed the dose due to pen issue and had hyperglycemic coma (product complaint (b)(4)/lot unknown).The event of hyperglycemic coma was considered as serious due to its medical significance.She had recovered from the events.Corrective treatment was not provided.As of (b)(6) 2019, treatment with human insulin isophane suspension 70%/human insulin 30% was continued.The operator of humapen ergo unknown body type (both devices) and humapen savvio pink and his/her training status was not provided.The general model humapen ergo unknown body type (both devices) and humapen savvio pink duration of use was not provided.The suspect humapen ergo unknown body type (associated with pc (b)(4)) duration of use was approximately six months.The suspect humapen savvio pink duration of use was not provided (noted to be spoiled after a few months).The suspect humapen ergo unknown body type (associated with pc (b)(4)) duration of use was one day.The status of humapen ergo unknown body type (both devices) and humapen savvio pink was discontinued and their return was expected.However, none of the devices were returned to the manufacturer.The initial reporting consumer did not relate the events with human insulin isophane suspension 70%/human insulin 30% treatment.The initial reporting consumer related the events with product complaint associated with humapen ergo unknown body type (both devices) and humapen savvio pink.Update 13-sep-2019: all the documents received on 09-sep-2019 were processed at same time.Edit 25sep2019: updated medwatch fields for expedited device reporting.No new information added.Edit 02oct2019: updated medwatch fields for expedited device reporting.No new information added.Edit 02oct2019: updated medwatch fields for expedited device reporting.No new information added.Update 29oct2019: additional information received on 25oct2019 from the global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information for the suspect humapen ergo (unknown pen body type) device associated with product complaint (b)(4), the suspect humapen savvio (pink) device associated with product complaint (b)(4), and the suspect humapen ergo (unknown pen body type) device associated with product complaint (b)(4); none of which were returned to the manufacturer.Corresponding fields and narrative updated accordingly.
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Manufacturer Narrative
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B.5.Narrative field: new, updated and corrected information is referenced within the update statements in b.5.Please refer to update statement dated 29oct2019 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2019-00174 and 1819470-2019-00175 since there is more than one device implicated.Evaluation summary : a female patient reported that the injection screw of her humapen ergo was stuck and would not release insulin.She experienced diabetic hyperglycemic coma.The device was not returned to the manufacturer for investigation (batch number unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen 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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Search Alerts/Recalls
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