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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 Crack (1135); Fracture (1260); Improper or Incorrect Procedure or Method (2017); Device Fell (4014)
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 1819470-2021-00066 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 consumer who contacted the company to report adverse events and product complaint (pc), concerned a (b)(6) years old female patient of (b)(6) nationality.Medical history (complicating disease, allergic history, family medical history), previous drug adverse reaction and family drug adverse reaction were none.Concomitant medication included metformin and acarbose, for unknown indication.The patient received human insulin (rdna origin) injections (humulin r, 100u/ml) from cartridge via reusable device (humapen ergo ii), twice a day (12 units in the morning and 14 units in the evening), subcutaneously for the treatment of diabetes mellitus from around (b)(6) 2012.On an unknown date after starting human insulin therapy, she experienced high and unstable blood glucose during season change (no values and reference ranges were provided).In (b)(6) 2014, the whole pen body of the first humapen ergo ii was cracked and it was not so good to be used (pc (b)(4)/ lot number 1107d02).She was hospitalized in (b)(6) 2016, around (b)(6) 2017 and around (b)(6) 2020, respectively due to high and unstable blood glucose.In (b)(6) 2021, there was something at her home, which led to excessive internal heat, she got angry and her blood pressure was not good.The blood pressure was also high and did not sleep well.In around (b)(6) 2021, the black injection screw of the second humapen ergo ii was dropped and could not be used anymore (pc (b)(4)/ lot number 1210d03).Reportedly, she disassembled the both humapen ergo ii devices later, assembled it back and continued to use (this was considered as an improper use of the devices).On an unknown date, her blood pressure was 140-150 (up pressure (systolic pressure) or down pressure (diastolic pressure) were not obtained).On an unknown date, her blood pressure was 70-110, around 80-120, and at the same time, her pre-prandial blood glucose measured on (b)(6) 2021 was 9.4 (no units were provided).Because of the perennial injection of human insulin, her belly had been punctured by needles.As of (b)(6) 2021, she changed to her human insulin dose to 16 units in the morning and 18 units in the evening by herself because the blood glucose was still high.She would be hospitalized if the blood glucose was still high.The patient was the operator of the humapen ergo ii devices and her training status was not provided.The humapen ergo ii devices model duration of use was not provided.The first suspect humapen ergo ii device duration of use was eight years as it was started since (b)(6) 2012.The second suspect humapen ergo ii device duration of use was five years as it was started since (b)(6) 2015.The use of both the suspect humapen ergo ii devices was ongoing and their return status was not provided.The reporting consumer did not know if the events were related to the human insulin therapy and did not provide a relatedness assessment for the events to the suspect humapen ergo ii devices.Edit 06-may-2021: upon review of the case, company analysis statement for the event of anger was added to the case and a technical issue due to which this event was missing from event assessment tab.No other changes were made to the case.Edit 07may2021: updated medwatch fields for expedited device reporting.No new information added.Edit 21may2021: updated medwatch fields for expedited device reporting.No new information added.
 
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 27may2021 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2021-00066 since there is more than one device implicated.Evaluation summary: a female patient reported that the whole pen body of her humapen ergo ii device was cracked and "it was not so good to be used." reportedly, she disassembled the device, assembled it back, and continued to use it.She experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1107d02, manufactured july 2011).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A batch threshold review determined the batch is not atypical with regard to dose accuracy issues.The patient continued to use the device after experiencing the initial complaint issue, taking the device apart and reassembling it.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.The patient reported that she had used the device for eight years.The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient continued to use the device after experiencing the initial alleged complaint issue and disassembling/reassembling the device.This misuse may be relevant to the event of increased blood glucose.The patient used the device beyond its recommended use period.It is unknown if this misuse 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 consumer who contacted the company to report adverse events and product complaint (pc), concerned a 68 years old female patient of han nationality.Medical history (complicating disease, allergic history, family medical history), previous drug adverse reaction and family drug adverse reaction were none.Concomitant medication included metformin and acarbose, for unknown indication.The patient received human insulin (rdna origin) injections (humulin r, 100u/ml) from cartridge via reusable device (humapen ergo ii), twice a day (12 units in the morning and 14 units in the evening), subcutaneously for the treatment of diabetes mellitus from around (b)(4)2012.On an unknown date after starting human insulin therapy, she experienced high and unstable blood glucose during season change (no values and reference ranges were provided).In (b)(4)2014, the whole pen body of the first humapen ergo ii was cracked and it was not so good to be used ((b)(4)/ lot number 1107d02).She was hospitalized in (b)(4)2016, around (b)(4)2017 and around (b)(4)2020, respectively due to high and unstable blood glucose.In (b)(4)2021, there was something at her home, which led to excessive internal heat, she got angry and her blood pressure was not good.The blood pressure was also high and did not sleep well.In around (b)(4)2021, the black injection screw of the second humapen ergo ii was dropped and could not be used anymore ((b)(4)/ lot number 1210d03).Reportedly, she disassembled the both humapen ergo ii devices later, assembled it back and continued to use (this was considered as an improper use of the devices).On an unknown date, her blood pressure was 140-150 (up pressure (systolic pressure) or down pressure (diastolic pressure) were not obtained).On an unknown date, her blood pressure was 70-110, around 80-120, and at the same time, her pre-prandial blood glucose measured on (b)(4)2021 was 9.4 (no units were provided).Because of the perennial injection of human insulin, her belly had been punctured by needles.As of (b)(4)2021, she changed to her human insulin dose to 16 units in the morning and 18 units in the evening by herself because the blood glucose was still high.She would be hospitalized if the blood glucose was still high.The patient was the operator of the humapen ergo ii devices and her training status was not provided.The humapen ergo ii devices model duration of use was not provided.The first suspect humapen ergo ii device duration of use was eight years as it was started since (b)(4)2012.The second suspect humapen ergo ii device duration of use was five years as it was started since (b)(4)2015.The use of both the suspect humapen ergo ii devices was ongoing and they were not returned to the manufacturer.The reporting consumer did not know if the events were related to the human insulin therapy and did not provide a relatedness assessment for the events to the suspect humapen ergo ii devices.Edit 06-may-2021: upon review of the case, company analysis statement for the event of anger was added to the case and a technical issue due to which this event was missing from event assessment tab.No other changes were made to the case.Edit 07may2021: updated medwatch fields for expedited device reporting.No new information added.Edit 21may2021: updated medwatch fields for expedited device reporting.No new information added.Update 27may2021: additional information received on 27may2021 from the global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, and device return status to not returned to manufacturer.Added date of manufacturer for (b)(4)associated with lot 1107d02 and 5556044 associated with lot 1210d03 of humapen ergo ii devices.Corresponding fields and narrative updated accordingly.
 
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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 Key11864854
MDR Text Key266471608
Report Number1819470-2021-00065
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 consumer,foreign
Type of Report Initial,Followup
Report Date 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMS9557
Device Lot Number1107D02
Was Device Available for Evaluation? No
Date Manufacturer Received05/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age68 YR
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