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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hyperglycemia (1905); Sweating (2444)
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 1819470-2020-00054 since there is more than one device implicated.
 
Event Description
Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned approximately a (b)(6) year-old elderly male patient of an unknown origin.Medical history and concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100 u/ml) from a cartridge via a reusable device humapen, unknown device and humapen ergo ii, at an unknown dose and frequency subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date.He started humapen ergo ii approximately in in 2013 or 2014, which was also considered as improper use.On an unknown date while taking human insulin isophane suspension 70%/human insulin 30% treatment he had blood glucose was high with fasting blood glucose was at 11.2 (units and reference range not provided) for which he was hospitalized.Approximately in 2020 he was discharged from the hospital.He was also sweating a lot due to humapen ergo ii issue (b)(4); lot : 1309d01), however specific issue and reason not provided.He also had issue with his first humapen, unknown device (b)(4); lot: unknown) also specific issue and reason not provided.Since unspecified date, he had an unspecified heart disease.Information regarding further hospitalization details, corrective treatments and outcome of the events was not provided.Human insulin isophane suspension 70%/human insulin 30% treatment was continued.The operator of humapen, unknown device and humapen ergo ii was unknown and his/her training status was not provided.The general model duration of use and suspect device humapen, unknown device durations of use were not provided.The general model humapen ergo ii duration of use was not provided and the suspect humapen ergo ii duration of use was approximately seven or six years as it was started approximately in 2013 or 2014.The action taken with humapen, unknown device was not provided however patient continued to use the humapen ergo ii and their return status was not reported.The reporting consumer did not provide any opinion on relatedness assessment between the events and human insulin isophane suspension 70%/human insulin 30% drug.The reporting consumer related the event of sweating to the humapen ergo ii device issue and did not provide relatedness assessment between the remaining events and humapen ergo ii device and all the events and humapen, unknown device.Update 12-may-2020: both the information received on 08-may-2020, 11-may-2020 and 13-may-2020 was processed together.Update 14-may-2020: additional information received from the quality department on 11-may-2020.Product complaint numbers (b)(4) were received again, however they were processed since the initial version.Upon review of initial information, narrative was updated with information regarding heart disease.Edit 15may2020: updated medwatch and (b)(4) (eu/ca) fields for expedited device reporting.No new information added.Update 18may2020: additional information received on 18may2020 from global product complaint database.Changed the lot number from unknown to 1309d01 for product complaint (b)(4) relating to the 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 statement dated 29jun2020 in the b.5.Field.No further follow up is planned.This report is associated with 1819470-2020-00054 since there is more than one device implicated.Evaluation summary: a male patient reported his humapen ergo ii device "didn't work well, and the injection button also didn't work well." the patient experienced increased blood glucose.The investigation of the returned device (batch number 1309d01, manufactured september 2013) found the device met functional testing requirements; however, the pen housing was cracked and too damaged to perform dose accuracy testing.The observed housing defects were consistent with field damage, and all internal components appeared normal.No malfunction was identified.The observed soft touch damage was consistent with field damage.The core instructions for use 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." based on the manufacturing date (september 2013) and no information provided regarding start of use date, the user likely used the device beyond its recommended use life.The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.The core instructions for use also state if any of the parts of your humapen ergo ii appear broken or damaged, do not use.There is evidence of improper use.The patient likely used the device beyond its approved use life.It is unknown if this is relevant to the event of increased blood glucose.
 
Event Description
Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned approximately a 60-70-year-old elderly male patient of an unknown origin.Medical history and concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100 u/ml) from a cartridge via a reusable device humapen, unknown device and humapen ergo ii, at an unknown dose and frequency subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date.He started humapen ergo ii approximately in in 2013 or 2014, which was also considered as improper use.On an unknown date while taking human insulin isophane suspension 70%/human insulin 30% treatment he had blood glucose was high with fasting blood glucose was at 11.2 (units and reference range not provided) for which he was hospitalized.Approximately in 2020 he was discharged from the hospital.He was also sweating a lot due to humapen ergo ii issue ((b)(4); lot : 1309d01), however specific issue and reason not provided.He also had issue with his first humapen, unknown device ((b)(4); lot: unknown) also specific issue and reason not provided.Since unspecified date, he had an unspecified heart disease.Information regarding further hospitalization details, corrective treatments and outcome of the events was not provided.Human insulin isophane suspension 70%/human insulin 30% treatment was continued.The operator of humapen, unknown device and humapen ergo ii was unknown and his/her training status was not provided.The general model duration of use and suspect device humapen, unknown device durations of use were not provided.The general model humapen ergo ii duration of use was not provided and the suspect humapen ergo ii duration of use was approximately seven or six years as it was started approximately in 2013 or 2014.The action taken with humapen, unknown device was not provided however patient continued to use the humapen ergo ii and their return status was not reported.The reporting consumer did not provide any opinion on relatedness assessment between the events and human insulin isophane suspension 70%/human insulin 30% drug.The reporting consumer related the event of sweating to the humapen ergo ii device issue and did not provide relatedness assessment between the remaining events and humapen ergo ii device and all the events and humapen, unknown device.Update 12-may-2020: both the information received on 08-may-2020, 11-may-2020 and 13-may-2020 was processed together.Update 14-may-2020: additional information received from the quality department on 11-may-2020.Product complaint numbers (b)(4) were received again, however they were processed since the initial version.Upon review of initial information, narrative was updated with information regarding heart disease.Edit 15may2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 18may2020: additional information received on 18may2020 from global product complaint database.Changed the lot number from unknown to 1309d01 for product complaint (b)(4) relating to the humapen ergo ii device.Corresponding fields and narrative updated accordingly.Update 29jun2020: additional information received on 25jun2020 from the global product complaint database.Entered the device specific safety summary (dsss).Updated the medwatch and european and canadian (eu/ca) device fields, malfunction from unknown to no, and device return status to returned to manufacturer.Added the date of manufacture and date returned to manufacturer for the suspect device associated with (b)(4).Entered the device specific safety summary (dsss).Updated the medwatch and european and canadian (eu/ca) device fields for the suspect device associated with (b)(4).Corresponding fields and narrative updated accordingly.Update 30jun2020: additional information received on 25jun2020 from the global product complaint database.No new information was added.
 
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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
MDR Report Key10070570
MDR Text Key195550918
Report Number1819470-2020-00053
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 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number1309D01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2020
Date Manufacturer Received06/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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