MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO, BURGUNDY/CLEAR; FOR TREATMENT PURPOSES

Model Number MS8930

Device Problem Mechanical Jam (2983)

Patient Problems Hyperglycemia (1905); Pain (1994); Ulceration (2116); Missed Dose (2561)

Event Date 06/08/2020

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 1819470-2020-00069 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 case, reported by a consumer via a patient support program (psp), concerned a (b)(6) year-old female patient of unknown origin.Medical history included hypertension and psychiatric disorder.Concomitant medications included carbamazepine for unknown episodes, lansoprazole as a stomach preventer, candesartan cilexetil for hypertension, diazepam, olanzapine and fluoxetine hydrochloride for psychiatric disorders and trazodone hydrochloride for sleep disturbances.The patient received human insulin (rdna origin) injections (humulin r) and human insulin isophane suspension (rdna origin) injections (humulin n) from cartridge via a reusable devices humapen ergo burgundy/clear and humapen luxura, burgundy, 40 iu-45 iu and 30 iu-35 iu respectively, thrice daily for the treatment of diabetes mellitus, beginning on (b)(6) 2006.Route of administration was not provided.On (b)(6) 2020, 14 years, after starting on human insulin, human insulin isophane suspension treatments, her pens were not giving the medicine when pressing as they were jammed as a result, she experienced blood glucose elevation (lot number: 0510a01, product complaint number: (b)(4); lot number: 1311b11, product complaint number: (b)(4)).Her blood glucose was 400-450.Also, due to not taking insulin, wounds were formed in her mouth and she was suffering pain due to wounds.On an unknown date, her blood glucose increased to 600.She administered extra dose of insulin to decrease her blood glucose level.She was not removing needle tip from the pen after administration, she was putting the pen to the refrigerator with needle tip.The event of high blood sugar was considered as serious due to its medical significance.Information regarding corrective treatment, outcome of the events and status of human insulin and human insulin isophane suspension treatments was not provided.The patient was the operator of the humapen ergo burgundy/clear and humapen luxura, burgundy and her training status was not provided.The humapen ergo burgundy/clear and humapen luxura, burgundy general duration of use was not provided.The suspect humapen ergo burgundy/clear and humapen luxura, burgundy duration of use was approximately fifteen years as they were started in 2005 or 2006.The status of humapen ergo burgundy/clear and humapen luxura, burgundy was not provided and their return was expected.The reporting consumer did not provide an opinion of relatedness between the events and human insulin, human insulin isophane suspension treatments.The reporting consumer related the elevated blood sugar with her psychological situation.The reporting consumer related the event of missed dose with product complaint associated with humapen ergo burgundy/clear and humapen luxura, burgundy and did not provide relatedness of remaining events with humapen ergo burgundy/clear and humapen luxura, burgundy.Update 16-jun-2020: documents received on 10-jun-2020 and 11-jun-2020 were processed at same time.Edit 16jun2020: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 40-year-old female patient of unknown origin.Medical history included hypertension and psychiatric disorder.Concomitant medications included carbamazepine for unknown episodes, lansoprazole as a stomach preventer, candesartan cilexetil for hypertension, diazepam, olanzapine and fluoxetine hydrochloride for psychiatric disorders and trazodone hydrochloride for sleep disturbances.The patient received human insulin (rdna origin) injections (humulin r) and human insulin isophane suspension (rdna origin) injections (humulin n) from cartridge via a reusable devices humapen ergo burgundy/clear and humapen luxura, burgundy, 40 iu-45 iu and 30 iu-35 iu respectively, thrice daily for the treatment of diabetes mellitus, beginning on (b)(6)2006.Route of administration was not provided.On (b)(6)2020, 14 years, after starting on human insulin, human insulin isophane suspension treatments, her pens were not giving the medicine when pressing as they were jammed as a result, she experienced blood glucose elevation (lot number: 0510a01, product complaint number: (b)(4); lot number: 1311b11, product complaint number: (b)(6)).Her blood glucose was 400-450.Also, due to not taking insulin, wounds were formed in her mouth and she was suffering pain due to wounds.On an unknown date, her blood glucose increased to 600.She administered extra dose of insulin to decrease her blood glucose level.She was not removing needle tip from the pen after administration, she was putting the pen to the refrigerator with needle tip.The event of high blood sugar was considered as serious due to its medical significance.Information regarding corrective treatment, outcome of the events and status of human insulin and human insulin isophane suspension treatments was not provided.The patient was the operator of the humapen ergo burgundy/clear and humapen luxura, burgundy and her training status was not provided.The humapen ergo burgundy/clear and humapen luxura, burgundy general duration of use was not provided.The suspect humapen ergo burgundy/clear and humapen luxura, burgundy duration of use was approximately fifteen years as they were started in 2005 or 2006.The status of humapen ergo burgundy/clear and humapen luxura, burgundy was not provided and their return was expected.The reporting consumer did not provide an opinion of relatedness between the events and human insulin, human insulin isophane suspension treatments.The reporting consumer related the elevated blood sugar with her psychological situation.The reporting consumer related the event of missed dose with product complaint associated with humapen ergo burgundy/clear and humapen luxura, burgundy and did not provide relatedness of remaining events with humapen ergo burgundy/clear and humapen luxura, burgundy.Update 16-jun-2020: documents received on 10-jun-2020 and 11-jun-2020 were processed at same time.Edit 16jun2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 22jul2020: additional information received on 17jul2020 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields; and added the date of manufacture and device age for the suspect devices associated with (b)(4).Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

B.5.Narrative field; new updated and corrected information is referenced within the update statements in b.5.Please refer to statement dated 22jul2020 in the b.5.Field.No further follow up is planned.This report is associated with 1819470-2020-00069 since there is more than one device implicated.Evaluation summary: a female patient reported that her humapen ergo device was not giving the medicine when pressing and was jammed.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 0510a01, manufactured october 2005).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 jammed devices.All humapen ergo devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The patient reported that she stores the device with the needle attached.The core instructions for use state to remove the needle after completing each injection and do not store the pen with the needle attached.The patient also reported using the device since 2005 or 2006.The core instructions for use states the humapen ergo device has been designed to be used for up to 3 years after first use.There is evidence of improper use and storage.The patient stored the device with the needle attached.This misuse may not be relevant to the complaint and the event of increased blood glucose.The patient used the device beyond the recommended use period.This misuse may be relevant to the complaint and the event of increased blood glucose.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 40-year-old female patient of unknown origin.Medical history included hypertension and psychiatric disorder.Concomitant medications included carbamazepine for unknown episodes, lansoprazole as a stomach preventer, candesartan cilexetil for hypertension, diazepam, olanzapine and fluoxetine hydrochloride for psychiatric disorders and trazodone hydrochloride for sleep disturbances.The patient received human insulin (rdna origin) injections (humulin r) and human insulin isophane suspension (rdna origin) injections (humulin n) from cartridge via a reusable devices humapen ergo burgundy/clear and humapen luxura, burgundy, 40 iu-45 iu and 30 iu-35 iu respectively, thrice daily for the treatment of diabetes mellitus, beginning on (b)(6) 2006.Route of administration was not provided.On (b)(6) 2020, 14 years, after starting on human insulin, human insulin isophane suspension treatments, her pens were not giving the medicine when pressing as they were jammed as a result, she experienced blood glucose elevation (lot number: 0510a01, product complaint number: (b)(4); lot number: 1311b11, product complaint number: (b)(4)).Her blood glucose was 400-450.Also, due to not taking insulin, wounds were formed in her mouth and she was suffering pain due to wounds.On an unknown date, her blood glucose increased to 600.She administered extra dose of insulin to decrease her blood glucose level.She was not removing needle tip from the pen after administration, she was putting the pen to the refrigerator with needle tip.The event of high blood sugar was considered as serious due to its medical significance.Information regarding corrective treatment, outcome of the events and status of human insulin and human insulin isophane suspension treatments was not provided.The patient was the operator of the humapen ergo burgundy/clear and humapen luxura, burgundy and her training status was not provided.The humapen ergo burgundy/clear and humapen luxura, burgundy general duration of use was not provided.The suspect humapen ergo burgundy/clear and humapen luxura, burgundy duration of use was approximately fifteen years as they were started in 2005 or 2006.The status of humapen ergo burgundy/clear and humapen luxura, burgundy was not provided and their return was expected.The reporting consumer did not provide an opinion of relatedness between the events and human insulin, human insulin isophane suspension treatments.The reporting consumer related the elevated blood sugar with her psychological situation.The reporting consumer related the event of missed dose with product complaint associated with humapen ergo burgundy/clear and humapen luxura, burgundy and did not provide relatedness of remaining events with humapen ergo burgundy/clear and humapen luxura, burgundy.Update 16-jun-2020: documents received on 10-jun-2020 and 11-jun-2020 were processed at same time.Edit 16jun2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 22jul2020: additional information received on 17jul2020 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields; and added the date of manufacture and device age for the suspect devices associated with pc (b)(4) and (b)(4).Corresponding fields and narrative updated accordingly.Update 06-aug-2020: additional information was received from the local affiliate (rcp) on 04-aug-2020, added one suspect device (second device) humapen ergo burgundy/clear.Processed product complaint number (b)(4) accordingly.Updated causality statement and narrative with new information.Update 19aug2020: additional information received on 13aug2020 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields, malfunction from unknown to no, and device return status to returned to manufacturer; and added the date of manufacture and date returned to manufacturer for the suspect device associated with pc (b)(4).Updated the device specific safety summaries (dsss), medwatch and european and canadian (eu/ca) device fields, malfunction from unknown to no, and device return status to returned to manufacturer; added the unique device identifier (udi) number, date of manufacture and date returned to manufacturer for the suspect devices associated with pc (b)(4) and (b)(4).Corresponding fields and narrative updated accordingly.Edit 09sep2020: updated medwatch fields for expedited device reporting.No new information added.

Manufacturer Narrative

B.5.Narrative field; new updated and corrected information is referenced within the update statements in b.5.Please refer to statement dated 19aug2020 in the b.5.Field.No further follow up is planned.This report is associated with 1819470-2020-00069 and 1819470-2020-00103 since there is more than one device implicated.Evaluation summary.A female patient reported that her humapen ergo device was not giving the medicine when pressing and was jammed.The patient experienced increased blood glucose.Investigation of the returned device (batch 0510a01, manufactured october 2005) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The patient reported that she stores the device with the needle attached.The core instructions for use state to remove the needle after completing each injection and do not store the pen with the needle attached.The patient also reported using the device since 2005 or 2006.The core instructions for use states the humapen ergo device has been designed to be used for up to 3 years after first use.There is evidence of improper use and storage.The patient stored the device with the needle attached.This misuse may not be relevant to the complaint and the event of increased blood glucose.The patient used the device beyond the recommended use period.This misuse is not likely relevant to the event of increased blood glucose since the device met functional requirements.

• Brand Name: HUMAPEN ERGO, BURGUNDY/CLEAR
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 10180916
• MDR Text Key: 201177903
• Report Number: 1819470-2020-00070
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K982842
• 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: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS8930
• Device Lot Number: 0510A01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR