MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA BURGUNDY; FOR TREATMENT PURPOSES

Model Number MS9662

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Injury  

Manufacturer Narrative

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 1819470-2020-00065 since there is more than one device implicated.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited fetal case of a retrospectively reported maternal case, reported by a consumer via a patient support program (psp), concerned a baby patient of unknown age of gestation, gender or origin.The mother was (b)(6) year-old.Her medical history included current pregnancy with advanced age, diabetes mellitus, three previous pregnancies (two abortions and one premature baby) and historical drugs human insulin isophane suspension (rdna origin) injections (humulin n) and human insulin (rdna origin) injections (humulin r) during her third pregnancy.She did not receive any concomitant medication.She did receive during current pregnancy both human insulin (rdna origin) injections (humulin r), 80 international units (iu), three times daily and human insulin isophane suspension (rdna origin) injections (humulin n), 10 iu daily, both via cartridge via reusable pens (humapen luxura burgundy), for the treatment of diabetes mellitus and beginning on (b)(6) 2020; routes of administration were not reported.The last menstrual period and estimated due date were not reported.The fetus was exposed to human insulin and human insulin isophane suspension for approximately two weeks.No prenatal testing results were provided.The mother experienced issues with both humapens luxura: the piston of one failed and the other one was sticked; because of that, she was not able to take the insulins dosage completely (product complaint (b)(4)/lot 1308b02; product complaint (b)(4)/lot 1308b02).On unspecified date, her blood glucose level was increased to 340-350 (no units or reference ranges were provided) and her hba1c level was 10.8.Then, on (b)(6) 2020, her physician found out that her baby was dead on her womb.As of (b)(6) 2020, no information regarding mode of delivery was reported, but it was known that, on (b)(6) 2020, she would have an operation.No further complications were reported.The operator of the humapens luxura and his or her training status were not provided.The humapen luxura model and suspect humapens luxura duration of use was of four or five years.The action taken with the suspect humapens luxura was not provided and their return was expected.The reporting consumer did not provide an assessment of relatedness between the events, human insulin and human insulin isophane suspension therapies or the humapens luxura; the exposure event was entered for tracking purposes.This fetus case is associated with another fetus case (previous pregnancy, same mother) due to same reporter: (b)(4).Edit 04jun2020: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Update 08-jun-2020: information was received on 03-jun-2020 contained product complaint (pc) number.Pc number was processed accordingly and no new information was added to the case.

Manufacturer Narrative

A follow-up report will be submitted when the final evaluation is completed.B.5.Narrative field: new, updated and corrected information is referenced within the update statements in b.5.Please refer to update statement(s) dated 18jun2020 in the b.5.Field.This report is associated with 1819470-2020-00065 since there is more than one device implicated.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited retrospectively reported maternal case, reported by a consumer via a patient support program (psp), concerned a 37-year-old female patient of unknown origin.Medical history included current pregnancy with advanced age, diabetes mellitus, three previous pregnancies (two abortions and one premature baby) and historical drugs human insulin isophane suspension (rdna origin) injections (humulin n) and human insulin (rdna origin) injections (humulin r) during her third pregnancy.She did not receive any concomitant medication.The mother did receive both human insulin (rdna origin) injections (humulin r), 8 international units (iu), three times daily and human insulin isophane suspension (rdna origin) injections (humulin n), 10 iu daily, both via cartridge via reusable pens (humapen luxura burgundy), for the treatment of diabetes mellitus and beginning on (b)(6) 2020; routes of administration were not reported.Her last menstrual period and estimated due date were not reported.The fetus was exposed to human insulin and human insulin isophane suspension for approximately two weeks.No prenatal testing results were provided.The mother experienced issues with both humapens luxura: the piston of one failed and the other one was sticked; because of that, she was not able to take the insulins dosage completely (product complaint (b)(4)/lot 1308b02; product complaint (b)(4)/lot 1308b02).On unspecified date, her blood glucose level was increased to 340-350 (no units or reference ranges were provided) and her hba1c level was 10.8.Then, on (b)(6) 2020, her physician found out that her baby was dead on her womb.She would continue with human insulin and human insulin isophane suspension therapies.As of (b)(6) 2020, no information regarding mode of delivery was reported, but it was known that, on (b)(6) 2020, she would have an operation.No further complications were reported.The operator of the humapens luxura and his or her training status were not provided.The humapen luxura model and suspect humapens luxura duration of use was of four or five years.The action taken with the suspect humapens luxura was not provided and their return was expected.The reporting consumer did not provide an assessment of relatedness between the events, human insulin and human insulin isophane suspension therapies or the humapens luxura; the exposure event was entered for tracking purposes.This maternal case is associated with a fetus case (previous pregnancy, same mother) due to same reporter: (b)(4).Edit 04jun2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 08-jun-2020: information was received on 03-jun-2020 contained product complaint (pc) number.Pc number was processed accordingly and no new information was added to the case.Edit 18-jun-2020: upon review of initial information received on 22-may-2020, this report initially considered an infant case was amended to reflect a maternal case.Added: laboratory test, serious events abortion spontaneous and blood glucose increased, non-serious events glycosylated haemoglobin increased, maternal exposure during pregnancy and incorrect dose administered.Updated: occupation of the reporters, information in parent tab was removed and added to patient tab (initials, date of birth, age, gender and medical history), dose was corrected from 80 to 8 international units, routes of administration from transplacental to unknown and actions taken from not applicable to no change.Deleted: serious event foetal death and non-serious event foetal exposure during pregnancy.

Manufacturer Narrative

B.5.Narrative field: new, updated and corrected information is referenced within the update statements in b.5.Please refer to update statement dated 14jul2020 in the b.5.Field.This report is associated with 1819470-2020-00065 since there is more than one device implicated.No further follow-up is planned.Evaluation summary: the spouse of a female patient reported that his wife's humapen luxura device had an issue, the "black stick" was not moving.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1308b02, manufactured august 2013).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the device batch did not identify any atypical findings with regard to injections screw/ratchet not moving and a complaint history review and batch threshold review for the device batch did not identify any atypical findings with regard to dose accuracy issues.All humapen luxura 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.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited retrospectively reported maternal case, reported by a consumer via a patient support program (psp), concerned a 37-year-old female patient of unknown origin.Medical history included current pregnancy with advanced age, diabetes mellitus, three previous pregnancies (two abortions and one premature baby) and historical drugs human insulin isophane suspension (rdna origin) injections (humulin n) and human insulin (rdna origin) injections (humulin r) during her third pregnancy.She did not receive any concomitant medication.The mother did receive both human insulin (rdna origin) injections (humulin r), 8 international units (iu), three times daily and human insulin isophane suspension (rdna origin) injections (humulin n), 10 iu daily, both via cartridge via reusable pens (humapen luxura burgundy), for the treatment of diabetes mellitus and beginning on (b)(6) 2020; routes of administration were not reported.Her last menstrual period and estimated due date were not reported.The fetus was exposed to human insulin and human insulin isophane suspension for approximately two weeks.No prenatal testing results were provided.The mother experienced issues with both humapens luxura: the piston of one failed and the other one was sticked; further described, the black stick in one of them was not moving and the back of the other pen was going down via jamming when pressing (product complaint (b)(4)/lot 1308b02 and pc (b)(4)/lot 1308b02).Due to that, she was not able to take the insulins dosage completely.On unspecified date, her blood glucose level was increased to 340-350 (no units or reference ranges were provided) and her hba1c level was 10.8.Then, on (b)(6) 2020, her physician found out that her baby was dead on her womb.She would continue with human insulin and human insulin isophane suspension therapies.As of 22-may-2020, no information regarding mode of delivery was reported, but it was known that, on (b)(6) 2020, she would have an operation.No further complications were reported.The operator of the humapen luxura (burgundy) devices and his or her training status was not provided.The humapen luxura (burgundy) model and suspect duration of use was of four or five years.The action taken with the suspect humapen luxura (burgundy) devices was not provided and their return was expected.However, the suspect humapen luxura (burgundy) devices associated with product complaint numbers (b)(4) and (b)(4) were not returned to the manufacturer.The reporting consumer did not provide an assessment of relatedness between the events, human insulin and human insulin isophane suspension therapies or the humapen luxura (burgundy) devices; the exposure event was entered for tracking purposes.This maternal case is associated with a fetus case (previous pregnancy, same mother) due to same reporter: (b)(4).Edit 04jun2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 08-jun-2020: information was received on 03-jun-2020 contained product complaint (pc) number.Pc number was processed accordingly and no new information was added to the case.Edit 18-jun-2020: upon review of initial information received on 22-may-2020, this report initially considered an infant case was amended to reflect a maternal case.Added: laboratory test, serious events abortion spontaneous and blood glucose increased, non-serious events glycosylated haemoglobin increased, maternal exposure during pregnancy and incorrect dose administered.Updated: occupation of the reporters, information in parent tab was removed and added to patient tab (initials, date of birth, age, gender and medical history), dose was corrected from 80 to 8 international units, routes of administration from transplacental to unknown and actions taken from not applicable to no change.Deleted: serious event foetal death and non-serious event foetal exposure during pregnancy.Update 14jul2020: additional information received on 13jul2020 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.Added date of manufacturer for the suspect humapen luxura (burgundy) devices associated with product complaint numbers (b)(4) and (b)(4), which were not returned to the manufacturer.Corresponding fields and narrative updated accordingly.Edit 16jul2020: updated european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 16jul2020: the date of previous update statement was amended to reflect the statement was written on 16jul2020 (not 17jul2020).

• Brand Name: HUMAPEN LUXURA BURGUNDY
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis, in
• MDR Report Key: 10128901
• MDR Text Key: 194473586
• Report Number: 1819470-2020-00066
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K142518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9662
• Device Lot Number: 1308B02
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 37 YR