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

Model Number MS9557

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problems Hypoglycemia (1912); Memory Loss/Impairment (1958); Diabetic Ketoacidosis (2364)

Event Date 01/31/2016

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.

Event Description

Lilly case id: (b)(6) this report is associated with product compliant: (b)(4).This solicited case reported by a consumer via a patient support program (psp), with additional information from initial reporting consumer, concerned a (b)(6) female patient.Medical history included spinal nerve was not good and periodontitis.Concomitant medications included insulin glargine for unknown indication.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) via reusable pen (humapen ergo ii and humapen unknown), 18-20 units in the morning and 10-14 units at night according to blood sugar levels (or 20 units each morning and above 10 in units each evening, conflicting information), subcutaneously for the treatment of diabetes beginning in 2003 (or 2000, conflicting information).On unspecified date while on human insulin isophane suspension 70%/ human insulin 30%, she often experiences symptoms of hypoglycemia (no values provided).On unspecified date according to the advice of outpatient physician, dose was changed to above 10iu each morning and 8iu each evening.Sometime in 2008, her humapen unknown was leaking (associated product complaint (pc) 3991089/ lot number unknown).In 2013 while on treatment, she experienced her memory was reduced.In 2016 while on treatment, she was hospitalized due to high blood sugar (no values provided) and ketone body poisoning.Sometime in 2016, the cartridge holder of her humapen ergo ii was cracked (associated pc 3991091/ lot number 0904d05).Under suggestion of attending doctor, human insulin isophane suspension 70%/ human insulin 30% was stopped and human insulin (rdna origin) via reusable pen (humapen ergo ii) (humulin r) was started subcutaneously at unknown dosage regimen.As reported, in (b)(6) 2016 while on human insulin isophane suspension 70%/ human insulin 30% (conflicting information), she had vomiting, fever and coma due to all of these events she was hospitalized on unknown date.She was in coma for more than 70 hours and she was hospitalized for 15 days.No more details regarding discharge date as well as treatment and laboratory tests done while hospitalized were provided.Inpatient doctor reported that she had antibodies to human insulin isophane suspension 70%/ human insulin 30% and as a consequence she switched human insulin isophane suspension 70%/ human insulin 30% to insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) unknown formulation (humalog mix25).On unknown date while on human insulin or insulin lispro protamine suspension 75%/ insulin lispro 25%, she appeared hypoglycemia (no values provided).Under the suggestion of outpatient physician, human insulin was changed to 12 to 15iu each morning, 6iu each noon, and 8iu each evening.Information regarding corrective treatment, outcome of the events and insulin lispro protamine suspension 75%/ insulin lispro 25% was unknown.Human insulin was continued.The user of the humapen and the humapen ergo ii, and their training status was not provided.The humapen model and suspect humapen durations of use were not provided but started from about 2000 to about 2008.The humapen ergo ii model and suspect humapen ergo ii durations of use were not provided but started from about 2008 nag was ongoing.The status of the humapen was unknown.The reporting consumer did not know if the events were related to human insulin isophane suspension 70%/ human insulin 30%; did not know if the second event of hypoglycemia was related to human insulin and did not provide a relatedness assessment between the rest of the events and human insulin; and did not provide a relatedness assessment between the events and insulin lispro protamine suspension 75%/ insulin lispro 25%.No follow-up would be requested since after several attempts the reporter could not be contacted.Treating physician contact details were not provided.Update 22-nov-2016: information received from the psp on 18-nov-2016.Added no follow-up paragraph.No additional information was added to the case.Update 23-nov-2016: information regarding pc number was obtained on 03-nov-2016, it was processed previously and rejected and no additional information included on case.Update 15-may-2017: additional information received from the initial reporter via a psp on 10-may-2017.Added origin of the patient; medical history of periodontitis; three blood glucose lab data; concomitant medication of insulin glargine; two doses and start date conflicting information for humulin 70/30, two doses for suspect humulin 70/30; suspect drug of humalog mix25 and humulin r; suspect unknown lot number humapen and suspect lot number 0904d05 humapen ergo ii; the non-serious events of memory impairment and two hypoglycemia; the serious events of blood glucose increased and ketosis.Updated weight and height of the patient.Updated narrative with new information.Update 17-may-2017: additional information was received from the responsible complaint person on 11-may-2017.Pc reference numbers were processed and pc details were added to the narrative.No further changes were done.Update 18may2017: upon review, this case was opened to updated the medwatch and european and canadian required device reporting elements for regulatory reporting.

Manufacturer Narrative

Narrative field; new updated and corrected information is referenced within the update statements.  no further follow up is planned.Evaluation summary: a female patient reported the cartridge holder of her humapen ergo ii device was cracked.The patient experienced increased blood glucose levels.The investigation of the returned device (batch number (b)(4), manufactured april 2009) found that the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The investigation also found the cartridge holder thread end was cracked due to exposure to an unknown chemical while in the field.The damage observed to the cartridge holder did not affect the functionality of the device.The user manual describes the proper care and storage of the device and states "do not use alcohol, hydrogen peroxide, bleach, cover in liquid or apply lubrication such as oil, as this could damage the pen." there is evidence of improper use or storage.The cartridge holder was cracked due to exposure to an unknown chemical while in the field (not related to the manufacturing process).Since the cartridge holder crack did not affect functionality of the device, it is likely this is not relevant to the increased blood glucose.

Event Description

Lilly case id: (b)(4).This solicited case reported by a consumer via a patient support program (psp), with additional information from initial reporting consumer, concerned a (b)(6) year-old (b)(6) female patient.Medical history included spinal nerve was not good and periodontitis.Concomitant medications included insulin glargine for unknown indication.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) via reusable pen (humapen ergo ii and humapen unknown), 18-20 units in the morning and 10-14 units at night according to blood sugar levels (or 20 units each morning and above 10 in units each evening, conflicting information), subcutaneously for the treatment of diabetes beginning in 2003 (or 2000, conflicting information).On unspecified date while on human insulin isophane suspension 70%/ human insulin 30%, she often experiences symptoms of hypoglycemia (no values provided).On unspecified date according to the advice of outpatient physician, dose was changed to above 10iu each morning and 8iu each evening.Sometime in 2008, her humapen unknown was leaking (associated product complaint (pc) (b)(4)/ lot number unknown).In 2013 while on treatment, she experienced her memory was reduced.In 2016 while on treatment, she was hospitalized due to high blood sugar (no values provided) and ketone body poisoning.Sometime in 2016, the cartridge holder of her humapen ergo ii was cracked (associated pc (b)(4)/ lot number 0904d05).Under suggestion of attending doctor, human insulin isophane suspension 70%/ human insulin 30% was stopped and human insulin (rdna origin) via reusable pen (humapen ergo ii) (humulin r) was started subcutaneously at unknown dosage regimen.As reported, in (b)(6) 2016 while on human insulin isophane suspension 70%/ human insulin 30% (conflicting information), she had vomiting, fever and coma due to all of these events she was hospitalized on unknown date.She was on coma for more than 70 hours and she was hospitalized for 15 days.No more details regarding discharge date as well as treatment and laboratory tests done while hospitalized were provided.Inpatient doctor reported that she had antibodies to human insulin isophane suspension 70%/ human insulin 30% and as a consequence she switched human insulin isophane suspension 70%/ human insulin 30% to insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) unknown formulation (humalog mix25).On unknown date while on human insulin or insulin lispro protamine suspension 75%/ insulin lispro 25%, she appeared hypoglycemia (no values provided).Under the suggestion of outpatient physician, human insulin was changed to 12 to 15iu each morning, 6iu each noon, and 8iu each evening.Information regarding corrective treatment, outcome of the events and insulin lispro protamine suspension 75%/ insulin lispro 25% was unknown.Human insulin was continued.The user of the humapen and the humapen ergo ii, and their training status was not provided.The humapen model and suspect humapen durations of use were not provided but started from about 2000 to about 2008.The humapen ergo ii model and suspect humapen ergo ii was approximately 7 years, durations of use was not provided but started from about 2008 and was ongoing.The humapen ergo ii was returned on (b)(6) 2017.Evidence of improper use as the cartridge holder thread end was cracked due to exposure to an unknown chemical while in the field.The reporting consumer did not know if the events were related to human insulin isophane suspension 70%/ human insulin 30%; did not know if the second event of hypoglycemia was related to human insulin and did not provide a relatedness assessment between the rest of the events and human insulin; and did not provide a relatedness assessment between the events and insulin lispro protamine suspension 75%/ insulin lispro 25%.No follow-up would be requested since after several attempts the reporter could not be contacted.Treating physician contact details were not provided.Update 22-nov-2016: information received from the psp on 18-nov-2016.Added no follow-up paragraph.No additional information was added to the case.Update 23-nov-2016: information regarding pc number was obtained on 03-nov-2016, it was processed previously and rejected and no additional information included on case.Update 15-may-2017: additional information received from the initial reporter via a psp on (b)(6) 2017.Added origin of the patient; medical history of periodontitis; three blood glucose lab data; concomitant medication of insulin glargine; two doses and start date conflicting information for humulin 70/30, two doses for suspect humulin 70/30; suspect drug of humalog mix25 and humulin r; suspect unknown lot number humapen and suspect lot number 0904d05 humapen ergo ii; the non-serious events of memory impairment and two hypoglycemia; the serious events of blood glucose increased and ketosis.Updated weight and height of the patient.Updated narrative with new information.Update 17-may-2017: additional information was received from the responsible complaint person on (b)(6) 2017.Pc reference numbers were processed and pc details were added to the narrative.No further changes were done.Update 18may2017: upon review, this case was opened to updated the medwatch and (b)(4) required device reporting elements for regulatory reporting.Update 23jun2017.Additional information received 21jun2017 from the product complaint safety database.To the humapen ergo ii suspect device associated with lot 0904d05 entered the manufacture date, changed improper use to yes, entered the device specific safety summary (dsss), updated the (b)(4) device information, updated the medwatch field with the device information , added the approximate age of the device, and the narrative was updated accordingly.Update 20jul2017: upon internal review, updated device available for evaluation from yes to returned to manufacturer, added date returned to manufacturer, malfunction from unknown to no, medwatch fields, and the (b)(4) device fields.

• 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: 6616125
• MDR Text Key: 76824098
• Report Number: 1819470-2017-00090
• 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: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 0904D05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2009
• 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): Hospitalization
• Patient Age: 68 YR
• Patient Weight: 54