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

Model Number MS9557

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fainting (1847); Hypoglycemia (1912)

Event Type  No Answer Provided  

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 1819470-2016-00198, 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), with additional information from the initial reporter, concerned a (b)(6)-year-old (b)(6) female patient.Medical history was not reported.Concomitant medications included acarbose for an unknown indication of use.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injections (humalog mix25 300 u/ml) through cartridge via reusable pen (humapen ergo ii) 18 (no units) in the morning and 10 (no units) at night, subcutaneously for the treatment of diabetes mellitus beginning in may-2015.On an unspecified date, she injected an incorrect dose of insulin lispro protamine suspension 75%/ insulin lispro 25% due to it leaked out when pulled the needle after finished the injection.On (b)(6) 2016, she did not inject insulin lispro protamine suspension 75%/ insulin lispro 25% (pc 3679209/lot 1310d01).The humapen ergo ii was stored in refrigerator with a needle attached.Additionally on (b)(6) 2016 approximately one year and two months after beginning insulin lispro protamine suspension 75%/ insulin lispro 25%, her humapen (1508d03 pc.3721010) failed and due to this she was not sure if the first injection was injected into the body, so she injected twice and was not sure how much dosage she injected, due to this she had low blood glucose and fainted.The events of blood glucose decreased and faint were considered serious due to medically significant reasons and they were treated with chocolate and sugar and she was recovering for these events and did not appear again.Information regarding corrective treatments, outcome of the remain events and insulin lispro protamine suspension 75%/ insulin lispro 25% treatment status was not provided.The patient was the operator of the humapen ergo ii and her training status was not provided.The humapen ergo ii model duration of use was not provided but started since (b)(6)-2015.The reported humapen ergo ii duration of use was not provided.If the humapen ergo ii was returned, evaluation would be performed to determine if a malfunction had occurred.The status of the device was unknown.The reporting consumer did not provided an assessment of relatedness between the event of humapen ergo ii storage with a needle and insulin lispro protamine suspension 75%/ insulin lispro 25%.For the remaining events the reporting consumer was not sure if they are related with insulin lispro protamine suspension 75%/ insulin lispro 25% or the humapen ergo ii.This case is cross-referenced with the following case (b)(4).Edit 22-jun-2016: information received from the rcp on 21-jun-2016.Product complaint reference number was added to the narrative.No adverse event information was received.Added: initial reporter name, patient name.Updated: improper use or storage field of suspect device from no to yes; device available for evaluation from no to yes.Updated narrative with new information.Update 18-jul-2016: pc 3679209 received on 13-jun-2016 from local affiliate was found as already processed.No additional changes were performed to the case.Update 22-jul-2016: additional information received on 19-jul-2016.Added blood glucose decreased and fainted event as serious events.Added wrong dose administered as non serious event.Updated narrative.Edit 25jul2016.Case was opened to enter medwatch device fields for device mailing.No new information.Update 27-jul-2016: additional information was received on 26-jul-2016 from initial reporter via psp.Corrective treatment and outcome of events of blood glucose and syncope were updated.Narrative was updated accordingly.Edit 28-jul-2016: upon internal review of information received on 19-jul-2016.Added suspect device.Updated narrative with pc.Number.No more changes.29jul2016.Edit to update the medwatch fields on the device tabs for device mailing.No new information.

Manufacturer Narrative

This is a downgrade report, which no longer meets the criteria for expedited reporting.This report is associated with 1819470-2016-00198, 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), with additional information from the initial reporter, concerned a (b)(6) female patient.Medical history was not reported.Concomitant medications included acarbose for an unknown indication of use.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injections (humalog mix25 300 u/ml) through cartridge via reusable pen (humapen ergo ii) 18 (no units) in the morning and 10 (no units) at night, subcutaneously for the treatment of diabetes mellitus beginning in (b)(6) 2015.On an unspecified date, she injected an incorrect dose of insulin lispro protamine suspension 75%/ insulin lispro 25% due to it leaked out when pulled the needle after finished the injection.On (b)(6) 2016, she did not inject insulin lispro protamine suspension 75%/ insulin lispro 25% ((b)(4)/lot 1310d01).The humapen ergo ii was stored in refrigerator with a needle attached.Additionally on (b)(6) 2016 approximately one year and two months after beginning insulin lispro protamine suspension 75%/ insulin lispro 25% her humapen (lot number 1508d03/(b)(4)) failed and due to this she was not sure if the first injection was injected into the body so she injected twice (improper use) and was not sure how much dosage she injected, due to this she had low blood glucose and fainted.The events of blood glucose decreased and faint were considered serious due to medically significant reasons and they were treated with chocolate and sugar and she was recovering for these events and did not appear again.Information regarding corrective treatments, outcome of the remain events and insulin lispro protamine suspension 75%/ insulin lispro 25% treatment status was not provided.The patient was the operator of the humapen ergo ii and her training status was not provided.The humapen ergo ii model duration of use was not provided but started since (b)(6) 2015.The reported humapen ergo ii duration of use was approximately one year.The device returned and no malfunction was found.The reporting consumer did not provided an assessment of relatedness between the event of humapen ergo ii storage with a needle and insulin lispro protamine suspension 75%/ insulin lispro 25%.For the remaining events the reporting consumer was not sure if they are related with insulin lispro protamine suspension 75%/ insulin lispro 25% or the humapen ergo ii.This case is cross-referenced with the following (b)(4).Edit 22-jun-2016: information received from the rcp on 21-jun-2016.Product complaint reference number was added to the narrative.No adverse event information was received.Added: initial reporter name, patient name.Updated: improper use or storage field of suspect device from no to yes; device available for evaluation from no to yes.Updated narrative with new information.Update 18-jul-2016: pc 3679209 received on 13-jun-2016 from local affiliate was found as already processed.No additional changes were performed to the case.Update 22-jul-2016: additional information received on 19-jul-2016.Added blood glucose decreased and fainted event as serious events.Added wrong dose administered as non serious event.Updated narrative.Edit 25jul2016.Case was opened to enter medwatch device fields for device mailing.No new information.Update 27-jul-2016: additional information was received on 26-jul-2016 from initial reporter via psp.Corrective treatment and outcome of events of blood glucose and syncope were updated.Narrative was updated accordingly.Edit 28-jul-2016: upon internal review of information received on 19-jul-2016.Added suspect device.Updated narrative with pc.Number.No more changes.29jul2016.Edit to update the medwatch fields on the device tabs for device mailing.No new information.Edit 12-aug-2016: information received from the rcp on 20-jul-2016.Product complaint reference number was added to the narrative.No adverse event information was received.Update 23aug2016.Additional information received 22aug2016 from the product complaint safety database.To the second device tab added manufacture date, return date, changed malfunction to no, improper use to yes, entered the approximate age of the device, added the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, and the narrative was updated accordingly.Case was unlocked to add follow up significant follow up date.Update 08feb2017: upon review, this case was opened to update the medwatch fields for regulatory reporting.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 5850136
• MDR Text Key: 51293141
• Report Number: 1819470-2016-00196
• 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: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 1310D01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR