MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES

Model Number MS9557

Device Problems Break (1069); Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Insufficient Flow or Under Infusion (2182); Inaccurate Delivery (2339); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012); Device Fell (4014)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

Since the device is not being returned, evaluation for a malfunction is not possible.A follow-up report will be submitted when the final evaluation is completed as necessary.This report is associated with 1819470-2021-00046 and 1819470-2021-00047 since there is more than one device implicated.

Event Description

(b)(4).This solicited case reported by a consumer via a patient support program (psp), concerned a (b)(6)-year-old (at the time of initial report) male patient of unknown ethnicity.Medical history included obesity.Concomitant medication were not reported.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30; 100 u/ml), injections, from a cartridge via a reusable devices (humapen savvio 3ml red) and (humapen ergo ii), subcutaneously, for the treatment of diabetes mellitus, beginning approximately in 2005 (reported as 16 years prior to mar-2021).Dose and frequency, were not provided.Since an unspecified date, possibly while on human insulin isophane suspension 70%/human insulin 30% therapy, he was experiencing high blood glucose level which resulted in shivering while attaching the needle to take his dose; always suffered from high blood glucose level around 500 to 600 mg/dl and that they were measuring his blood glucose levels every two hours as it sometimes became unstable, decreased and increased as per food intake, he was taking 10 iu from human insulin isophane suspension 70%/human insulin 30% therapy and 10 iu from another insulin (apride as spelled it) when blood glucose level reached 500 mg/dl till it decreased to 200 mg/dl, as his physician advised.The blood glucose of 500 mg/dl event was considered to be serious by the company due to its medical significance.His first humapen was savvio red, it got impaired, they were keeping it in the refrigerator.Then his health care professional (hcp), gave him another humapen ergo ii when savvio got impaired but this ergo ii got broken as it fell on the ground while he was trying to take his dose, due to shivering which caused falling of humapen ergo ii on the ground.Things always fall form him while he was trying to attach parts of humapens to take his doses.When ergo ii got broken they tried to use first humapen savvio red but found that it was impaired as the screw was stuck when pressing to take the dose no human insulin isophane suspension 70%/human insulin 30% was released,therefore possibly he did not administered his dose (pc (b)(4)/lot number unknown and (b)(4)/lot number unknown).When they found these two humapens (savvio red and ergo ii), were not working, they got back to hcp and she gave them another humapen ergo ii.This humapen might be impaired as when he put the cartridge and closed it, it did not attach well which caused human insulin isophane suspension 70%/human insulin 30% therapy leakage and he thought that he did not take the dose so he re-took the dose again therefore possibly he received an inaccurate dose even possibly received an overdose((b)(4)/lot number unknown).They would check if the last humapen ergo ii was really impaired or not when he takes his evening dose.He was fat and the needle sometimes bent inside his body while taking the dose, also he was always anger.Finally, when the first humapen (possibly savvio red) got impaired they shifted to another insulin types as per physicians advice but these types were not effective for his case, so they returned back to human insulin isophane suspension 70%/human insulin 30% therapy, after returning to human insulin isophane suspension 70%/human insulin 30% therapy, they tried to insert the cartridge in another pen (non-company pen) but it did not fit.By (b)(6) 2021, he was not recovered from the events.Information regarding further corrective treatments, and additional details were not provided.Human insulin isophane suspension 70%/human insulin 30% therapy was on-going.The patient was the operator of the reusable devices and his training status was not provided.The general humapen savvio 3ml red and humapens ergo ii model duration of use were not reported.The suspect humapen savvio 3ml red and humapens ergo ii duration of use was unknown.The action taken with the suspects humapen savvio 3ml red and humapens ergo ii was not provided; since the device is not being returned, evaluation for a malfunction is not possible.The reporting consumer did not provide a relatedness assessment between the events and the reusabless humapen savvio 3ml red and humapens ergo ii.Edit 25-mar-2021: upon internal review on 24-mar-2021 of the initial information the cire report was attached in order to confirm the reusables humapens are ergo ii for the pcs (b)(4), the device componen information fields from humapens ergo ii were deleted, and the coding from the medication error of patient possible administered wrong humulin 70/30 dose due to a possible device issue, no ae was corrected from wrong drug administered to wrong dose administered and pc (b)(4) was processed properly.Edit 26mar2021: updated medwatch and european and (b)(6) (eu)/ca) 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 update statement(s) dated 06apr2021 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2021-00046 and 1819470-2021-00047 since there is more than one device implicated.Evaluation summary: an individual reported on behalf of a male patient that the cartridge holder of his humapen ergo ii device did not attach well, causing the insulin to leak.He thought he did not take the dose, so he took the dose again, possibly receiving an inaccurate dose or an overdose.The patient experienced a serious event of increased blood glucose and a non-serious event of blood glucose fluctuation.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.The core instructions for use states, "if you do not think you received your full dose, do not take another dose.Call lilly or your healthcare professional for assistance." there is evidence of improper use.The patient continued to use the device after the alleged insulin delivery issue.This may have been relevant to the non-serious event of blood glucose fluctuation.

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 66 year old (at the time of initial report) male patient of unknown ethnicity.Medical history included obesity.Concomitant medication were not reported.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30; 100 u/ml), injections, from a cartridge via a reusable devices (humapen savvio 3ml red) and (humapen ergo ii), subcutaneously, for the treatment of diabetes mellitus, beginning approximately in 2005 (reported as 16 years prior to mar2021).Dose and frequency, were not provided.Since an unspecified date, possibly while on human insulin isophane suspension 70%/human insulin 30% therapy, he was experiencing high blood glucose level which resulted in shivering while attaching the needle to take his dose; always suffered from high blood glucose level around 500 to 600 mg/dl and that they were measuring his blood glucose levels every two hours as it sometimes became unstable, decreased and increased as per food intake, he was taking 10 iu from human insulin isophane suspension 70%/human insulin 30% therapy and 10 iu from another insulin (apride as spelled it) when blood glucose level reached 500 mg/dl till it decreased to 200 mg/dl, as his physician advised.The blood glucose of 500 mg/dl event was considered to be serious by the company due to its medical significance.His first humapen was savvio red, it got impaired they were keeping it in the refrigerator.Then his health care professional (hcp), gave him another humapen ergo ii when savvio got impaired but this ergo ii got broken as it fell on the ground while he was trying to take his dose, due to shivering which caused falling of humapen ergo ii on the ground.Things always fall form him while he was trying to attach parts of humapens to take his doses.When ergo ii got broken they tried to use first humapen savvio red but found that it was impaired as the screw was stuck when pressing to take the dose no human insulin isophane suspension 70%/human insulin 30% was released, therefore possibly he did not administered his dose (pc 5512631/lot number unknown and 5512632/lot number unknown).When they found these two humapens (savvio red and ergo ii), were not working, they got back to hcp and she gave them another humapen ergo ii.This humapen might be impaired as when he put the cartridge and closed it, it did not attach well which caused human insulin isophane suspension 70%/human insulin 30% therapy leakage and he thought that he did not take the dose so he retook the dose again therefore possibly he received an inaccurate dose even possibly received an overdose (pc 5518427/lot number unknown).They would check if the last humapen ergo ii was really impaired or not when he takes his evening dose.He was fat and the needle sometimes bent inside his body while taking the dose, also he was always anger.Finally, when the first humapen (possibly savvio red) got impaired they shifted to another insulin types as per physicians advice but these types were not effective for his case, so they returned back to human insulin isophane suspension 70%/human insulin 30% therapy, after returning to human insulin isophane suspension 70%/human insulin 30% therapy, they tried to insert the cartridge in another pen (noncompany pen) but it did not fit.By (b)(6) 2021, he was not recovered from the events.Information regarding further corrective treatments, and additional details were not provided.Human insulin isophane suspension 70%/human insulin 30% therapy was ongoing.The patient was the operator of the reusable devices and his training status was not provided.The general humapen savvio 3ml red and humapens ergo ii model duration of use were not reported.The suspect humapen savvio 3ml red and humapens ergo ii duration of use was unknown.Neither the humapen savvio (red) associated with product complaint (b)(4).(unknown lot), nor the two humapen ergo ii associated with product complaint (b)(4) and product complaint (b)(4) (unknown lots) were returned to the manufacturer.The reporting consumer did not provide a relatedness assessment between the events and the reusabless humapen savvio 3ml red and humapens ergo ii.Edit 25mar2021: upon internal review on 24mar2021 of the initial information the cire report was attached in order to confirm the reusables humapens are ergo ii for the pcs 5518427 and 5512632, the device component information fields from humapens ergo ii were deleted, and the coding from the medication error of patient possible administered wrong humulin 70/30 dose due to a possible device issue, no ae was corrected from wrong drug administered to wrong dose administered and (b)(4) was processed properly.Edit 26mar2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 06apr2021: additional information received on 02apr2021 from global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information for the humapen savvio (red) associated with product complaint (b)(4)(unknown lot), and the two humapen ergo ii associated with product complaint (b)(4) and product complaint (b)(4) (unknown lots) which were not returned to the manufacturer.Updated device improper use or storage from no to yes for the humapen savvio (red) associated with product complaint (b)(4) and humapen ergo ii associated with product complaint (b)(4).Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 11575321
• MDR Text Key: 253503358
• Report Number: 1819470-2021-00045
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR