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

Model Number MS9557

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Neuropathy (1983)

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 1819470-2017-0052, 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 a product complaint (pc), with additional information from another consumer via psp, concerned a (b)(6) male patient of unknown origin.Medical history and concomitant medications were not reported.The patient received human insulin isophane suspension (rdna origin) injections (humulin n 100 u/ml) and human insulin (rdna origin) injections (humulin r 100 u/ml) through cartridges via two humapen ergo ii, beginning on (b)(6) 2014.Dosage regimen, route of administration, and therapy start date were not provided.On an unspecified date, his sugar level rose, and when he continued applying with his humapen ergo ii devices, the sugar level remained high; due to this he was hospitalized in order to have his sugar levels regularized and controlled (hospitalization dates were not provided).Since (b)(6) 2016 he had noticed that his humapen ergo ii devices were not working properly since the insulin did not come out and because of this he had been administrating the insulin with disposable syringes (lot number 1209d01; (b)(4)) (lot number 1209d01; (b)(4)).Sometime, he experienced charcot foot problem (diabetic foot) and on (b)(6) 2017 he was hospitalized, he would be discharged on (b)(6) 2017.Information regarding additional corrective treatments, outcome of the events, laboratory test, further hospitalization details, and human insulin isophane suspension and human insulin treatment status was not provided.The user of the humapen ergo ii and his/her training status were unknown.The humapen ergo ii model and suspect humapen ergo ii durations of use were not provided.The action taken of the suspect humapen ergo ii were not known.The humapen ergo ii devices were returned to the manufacturer on 15mar2017.The reporting consumers did not provide an assessment of relatedness between the events and human insulin isophane suspension and human insulin treatment or the device.Update 28-feb-2017: product complaint number was received on 23-feb-2017.Added humapen ergo ii as suspect device in order to process the complaint, and changed the formulation for human insulin and human insulin isophane suspension from unknown to cartridges.Narrative was updated accordingly.No further changes to the case.Update 01-mar-2017: upon review, this case was opened to update the medwatch fields for regulatory reporting.Update 03-mar-2017: upon reviewed on 03-mar-2017.No other information was added to this case from the receipt date on 22-feb-2017.No changes were made to this case.Edit 13-mar-2017: upon internal communications a (b)(4) was processed accordingly.No changes were made to this case.Update 05-apr-2017: additional information received on 03-apr-2017 from another reporting consumer via psp.Serious events of charcot foot problem was added.Narrative and fields were updated accordingly.Update 09apr2017: additional information received 07apr2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information, improper use and storage from no to yes, malfunction from unknown to no, and device return status to returned to manufacturer.Added lot number for the device, date of manufacturer and date returned to manufacturer for the device.Corresponding fields and narrative updated accordingly.Update 26apr2017: additional information received on 15mar2017 from global product complaint database added a new second suspect humapen ergo ii associate with (b)(4); and updated the narrative.

Manufacturer Narrative

Narrative field; new updated and corrected information is referenced within the update statements.No further follow up is planned.This is a downgrade report, wihich no longer meets the criteria for expedited reporting.This report is associated with 1819470-2017-00052, since there is more than one device implicated.Evaluation summary a male patient reported his humapen ergo ii device was "not functioning well, when he applied the liquid it does not flow." the patient experienced increased blood glucose.The investigation of the returned device (batch number 1209d01, manufactured september 2012) found that the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The duration of use was not provided by the patient; however, based on the time elapsed since the device was manufactured (september 2012), it is possible the patient used the device beyond its approved use life.The user manual states the humapen ergo ii device has been designed to be used for up to 3 years after first use.There is evidence of improper use.It is possible the patient used the device beyond its approved use life.This may not be relevant to the event of increased blood glucose.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp) with a product complaint (pc), with additional information from another consumer via psp, concerned a (b)(6) male patient of unknown origin.Medical history and concomitant medications were not reported.The patient received human insulin isophane suspension (rdna origin) injections (humulin n 100 u/ml) and human insulin (rdna origin) injections (humulin r 100 u/ml) through cartridges via two humapen ergo ii, beginning on (b)(6) 2014.Dosage regimen, route of administration, and therapy start date were not provided.On an unspecified date, his sugar level rose, and when he continued applying with his humapen ergo ii devices, the sugar level remained high; due to this he was hospitalized in order to have his sugar levels regularized and controlled (hospitalization dates were not provided).Since (b)(6) 2016 he had noticed that his humapen ergo ii devices were not working properly since the insulin did not come out and because of this he had been administrating the insulin with disposable syringes (lot number 1209d01; pc 3916959) (lot number 1209d01; pc 3976710).Sometime, he experienced charcot foot problem (diabetic foot) and on (b)(6) 2017 he was hospitalized, he would be discharged on (b)(6) 2017.Information regarding additional corrective treatments, outcome of the events, laboratory test, further hospitalization details, and human insulin isophane suspension and human insulin treatment status was not provided.The user of the humapen ergo ii and his/her training status were unknown.The humapen ergo ii model and suspect humapen ergo ii durations of use were not provided.The action taken of the suspect humapen ergo ii were not known.The humapen ergo ii devices were returned to the manufacturer on (b)(6) 2017.The reporting consumers did not provide an assessment of relatedness between the events and human insulin isophane suspension and human insulin treatment or the device.Update 28-feb-2017: product complaint number was received on (b)(6) 2017.Added humapen ergo ii as suspect device in order to process the complaint, and changed the formulation for human insulin and human insulin isophane suspension from unknown to cartridges.Narrative was updated accordingly.No further changes to the case.Update 03-mar-2017: upon review, this case was opened to update the medwatch fields for regulatory reporting.Update 03-mar-2017: upon reviewed on 03-mar-2017.No other information was added to this case from the receipt date on 22-feb-2017.No changes were made to this case.Edit 13-mar-2017: upon internal communications a pc number 3916959 was processed accordingly.No changes were made to this case.Update 05-apr-2017: additional information received on 03-apr-2017 from another reporting consumer via psp.Serious events of charcot foot problem was added.Narrative and fields were updated accordingly.Update 09apr2017: additional information received 07apr2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information, improper use and storage from no to yes, malfunction from unknown to no, and device return status to returned to manufacturer.Added lot number for the device, date of manufacturer and date returned to manufacturer for the device.Corresponding fields and narrative updated accordingly.Update 26apr2017: additional information received on 15mar2017 from global product complaint database added a new second suspect humapen ergo ii associate with product complaint 3976710; and updated the narrative.Update 12may2017: additional information received on 10may2017 from the global product complaint database added the device specific safety summary and manufactured date of the device; updated the malfunction field to no; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.Edit 23-may-2017: upon internal review on 23-may-2017, it was corrected demographic details of second reporting consumer and it was added possible discharge date in general database.No other changes were performed.

• 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: 6529901
• MDR Text Key: 73957076
• Report Number: 1819470-2017-00079
• 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: 05/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1209D01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/15/2017
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 04/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2012
• 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
• Treatment: INSULIN REGULAR
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR