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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES
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ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9557
Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Mechanical Jam (2983)
Patient Problem Hyperglycemia (1905)
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 1819470-2021-00041 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 via a psp, concerned a (b)(6)-years-old han male patient.Medical history included hand numbness, blood clot in the fundus artery, foot numbness and diabetes mellitus.Concomitant medications included metformin for the treatment of diabetes mellitus and many unknown medicines for unknown indication.The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) (humalog mix50) from cartridge via a humapen ergo ii subcutaneously, 16 units each in the morning and evening for type two diabetes mellitus beginning on an unspecified date in 2017 or 2018 (conflicting start date reported).On an unknown date, while administrating insulin lispro protamine suspension 50%/ insulin lispro 50%, humapen ergo ii button could not be pressed down, there was insulin lispro protamine suspension 50%/ insulin lispro 50% leaked out, as his hand would stain with the insulin lispro protamine suspension 50%/ insulin lispro 50% from humapen ergo ii (lot# 1708d03; pc# (b)(4)).Reportedly, he was worried that insulin lispro protamine suspension 50%/ insulin lispro 50% was administer incorrectly and it could not be injected in.On an unknown date, after starting insulin lispro protamine suspension 50%/ insulin lispro 50%, his blood glucose was too high and the blood glucose could not came down (values, units, reference range not provided).In the end of (b)(6) 2021, he was hospitalized because the high blood glucose and the hand and foot was numb.During the hospital stay, he changed the injection dose of insulin lispro protamine suspension 50%/ insulin lispro 50% from morning 16 units, evening 16 units before to morning 14 units, evening 14 units according to the physician advice.During the period of hospitalization check, the blood clot in the right eye was found.More information was not provided.As of (b)(6) 2021, in recent two months, insulin was seen leaking when the pen cap was pulled out from the humapen ego ii (pc no (b)(4)/lot no 1708d03), hand also got insulin during injection, the cartridge had ever been changed and tried, but insulin was still leaking, it was not the cartridge issue, it was unclear on specifically where the insulin leaking from.Information regarding the corrective treatment and the outcome of the events were not provided.The insulin lispro protamine suspension 50%/ insulin lispro 50% was continued.The patient was the operator of the humapen ergo ii and his training status was not provided.The general humapen ergo ii model duration of use was not reported but it was started in 2017 or 2018 (conflicting start date reported) and the suspect humapen ergo ii devices duration of use were not reported.Humapen ergo ii devices were continued and were not returned to the manufacturer.The reporting consumer did not report any relatedness assessment between the events and insulin lispro protamine suspension 50%/ insulin lispro 50%.The reporting consumer related the events of blood glucose increased and incorrect dose administered with humapen ergo ii while did not report any relatedness between the remaining events and humapen ergo ii.Update 03-mar-2021: additional information received on 01-mar-2021 from the initial reporter via the psp.This case was upgraded to serious due to upgradation of event: blood glucose increased from non-serious to serious.Added one serious event of hypoaesthesia and one non-serious event of thrombosis.Updated patient weight.Added one medical history of fundal hemorrhage and once concomitant medication.Added one dosage regimen, conflicting start date and updated action taken dechallenge and rechallenge results of suspect drug.Upon review updated operator of the humapen ergo ii.Updated narrative with new information accordingly.Update 07-mar-2021: additional information was received from initial reporting consumer via a psp on 02-mar-2021.Added: new suspect device humapen ergo ii and processed the pc accordingly.Narrative was updated with new information accordingly.Update 12-mar-2021: additional information was received from the initial reporter via a psp on 10-mar-2021.Added diabetes mellitus as medical history and indication for use from metformin.Narrative was updated accordingly with the new information.Update 12mar2021: additional information received on 08mar2021 from the global product complaint database.Entered the device specific safety summary (dsss).Updated the medwatch and european and (b)(6)(eu/(b)(6)) device fields, improper use and storage from yes to no, and device return status to returned to manufacturer.Added the date of manufacture for the suspect device associated with pc (b)(4).Corresponding fields and narrative updated accordingly.Edit 23mar2021: updated medwatch 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), with additional information from the initial reporter via a psp, concerned a 63-years-old han male patient.Medical history included hand numbness, blood clot in the fundus artery, foot numbness and diabetes mellitus.Concomitant medications included metformin for the treatment of diabetes mellitus and many unknown medicines for unknown indication.The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) (humalog mix50) from cartridge via a humapen ergo ii subcutaneously, 16 units each in the morning and evening for type two diabetes mellitus beginning on an unspecified date in 2017 or 2018 (conflicting start date reported).On an unknown date, while administrating insulin lispro protamine suspension 50%/ insulin lispro 50%, humapen ergo ii button could not be pressed down, there was insulin lispro protamine suspension 50%/ insulin lispro 50% leaked out, as his hand would stain with the insulin lispro protamine suspension 50%/ insulin lispro 50% from humapen ergo ii (lot 1708d03; (b)(4)).Reportedly, he was worried that insulin lispro protamine suspension 50%/ insulin lispro 50% was administer incorrectly and it could not be injected in.On an unknown date, after starting insulin lispro protamine suspension 50%/ insulin lispro 50%, his blood glucose was too high and the blood glucose could not came down (values, units, reference range not provided).In the end of (b)(6) 2021, he was hospitalized because the high blood glucose and the hand and foot was numb.During the hospital stay, he changed the injection dose of insulin lispro protamine suspension 50%/ insulin lispro 50% from morning 16 units, evening 16 units before to morning 14 units, evening 14 units according to the physician advice.During the period of hospitalization check, the blood clot in the right eye was found.More information was not provided.As of (b)(6) 2021, in recent two months, insulin was seen leaking when the pen cap was pulled out from the humapen ego ii (pc no (b)(4) /lot no 1708d03), hand also got insulin during injection, the cartridge had ever been changed and tried, but insulin was still leaking, it was not the cartridge issue, it was unclear on specifically where the insulin leaking from.Information regarding the corrective treatment and the outcome of the events were not provided.The insulin lispro protamine suspension 50%/ insulin lispro 50% was continued.The patient was the operator of the humapen ergo ii and his training status was not provided.The general humapen ergo ii model duration of use was not reported but it was started in 2017 or 2018 (conflicting start date reported) and the suspect humapen ergo ii devices duration of use were not reported.Humapen ergo ii with (b)(4) was continued and suspect device with (b)(4) was returned to the manufacturer on 04mar2021.The reporting consumer did not report any relatedness assessment between the events and insulin lispro protamine suspension 50%/ insulin lispro 50%.The reporting consumer related the events of blood glucose increased and incorrect dose administered with humapen ergo ii while did not report any relatedness between the remaining events and humapen ergo ii.Update 03-mar-2021: additional information received on 01-mar-2021 from the initial reporter via the psp.This case was upgraded to serious due to upgradation of event: blood glucose increased from non-serious to serious.Added one serious event of hypoaesthesia and one non-serious event of thrombosis.Updated patient weight.Added one medical history of fundal hemorrhage and once concomitant medication.Added one dosage regimen, conflicting start date and updated action taken dechallenge and rechallenge results of suspect drug.Upon review updated operator of the humapen ergo ii.Updated narrative with new information accordingly.Update 07-mar-2021: additional information was received from initial reporting consumer via a psp on 02-mar-2021.Added: new suspect device humapen ergo ii and processed the pc accordingly.Narrative was updated with new information accordingly.Update 12-mar-2021: additional information was received from the initial reporter via a psp on 10-mar-2021.Added diabetes mellitus as medical history and indication for use from metformine.Narrative was updated accordingly with the new information.Update 12mar2021: additional information received on 08mar2021 from the global product complaint database.Entered the device specific safety summary (dsss).Updated the medwatch and european and canadian (eu/ca) device fields, improper use and storage from yes to no, and device return status to returned to manufacturer.Added the date of manufacture for the suspect device associated with (b)(4).Corresponding fields and narrative updated accordingly.Edit 23mar2021: updated medwatch fields for expedited device reporting.No new information added.Update 13apr2021: additional information received on 13apr2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ 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 date of manufacturer and date returned to manufacturer for the device for (b)(4) associated with lot 1708d09 of humapen ergo ii device.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 update statement(s) dated 13apr2021 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2021-00041 since there is more than one device implicated.Evaluation summary: a male patient reported that the injection button could not be pushed down and that insulin was leaking when the pen cap was pulled out from his humapen ergo ii device.It was unclear from where the insulin was leaking.He experienced increased blood glucose.The investigation of the returned device (batch 1708d03, manufactured august 2017) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The patient continued to use the device after experiencing the complaint issue.The core instructions for use state if any of the parts of your humapen ergo ii appear broken or damaged, do not use.The core instructions for use also states to always carry a spare insulin pen in case your pen is lost or damaged.There is evidence of improper use.The patient continued to use the device after experiencing the alleged complaint issue.This misuse might not be relevant to the event of increased blood glucose since the device met functional requirements and met dose accuracy and glide (injection) force specifications.
 
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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 Key11563567
MDR Text Key257407377
Report Number1819470-2021-00042
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K151686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMS9557
Device Lot Number1708D03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2021
Date Manufacturer Received04/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age63 YR
Patient Weight73
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