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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 Failure to Advance (2524)
Patient Problems Hemorrhage/Bleeding (1888); 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.
 
Event Description
(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) asian female patient.Medical history was not provided.Concomitant medication included metformin and acarbose both used for the treatment of diabetes.The patient received unspecified lilly insulin (formulation unknown) via a reusable humapen (unknown) pen subcutaneously at a dose of 22 units in the morning and 20 units at night for the treatment of diabetes beginning on an unknown date (reported as over ten years).On an unknown date, while on an unspecified insulin, she was hospitalized due to her blood glucose levels were unstable no further hospitalization details were provided.After the hospitalization, the patient was switched to insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) subcutaneously via humapen (unknown) device at a dose of 26 units in morning, 24 units in night for the treatment of diabetes beginning on an unknown date in the year 2015.After the switch, her blood glucose still could not be decreased, further described as had intense spikes and fall.On an unknown date, she also received acetylsalicylic acid (aspirin) which was used for the treatment of unknown indication beginning on an unknown date.Dose, route of administration, indication and frequency were not provided.On an unknown date in (b)(6) 2017, she had ocular fundus were bleeding and she was not able to see clearly.On an unknown date, an eye laser surgery was done.She still had ocular fundus bleeding and her eyes could not see clearly.The event of retinal hemorrhage was considered as serious due to its medical significance.On an unknown date in (b)(6) 2018 (noted as a several days prior to the initial report date), the injection button of an unspecified humapen device could not be pushed ((b)(4)/lot number unknown).It was also noted that the device was obtained ten years ago.No further information regarding corrective treatment was provided.Outcome of the events serious blood glucose fluctuation, non-serious blood glucose increased and blood glucose decreased was unknown; the retinal hemorrhage outcome was not recovered.Insulin lispro protamine suspension 75%/insulin lispro 25% treatment was continued.Status of acetylsalicylic acid was not provided.The user of the humapen (unknown) device was unknown and his/her training status was not provided.The general device duration was not provided.The humapen unknown suspect device duration of use was over ten years.Return status was not provided.The initial reporting consumer considered that the event of blood glucose unstable, blood glucose decreased, and blood glucose increased as related to diet and exercise.The retinal haemorrhage was not related to insulin lispro protamine suspension 75%/insulin lispro 25% treatment but related to taking acetylsalicylic acid.The event of retinal haemorrhage was related to acetylsalicylic acid.The initial reporting consumer did not provide the relatedness of the events with the humapen device.Update 05-jul-2018: additional information received on 02-jul-2018.Product complaint number was received and product complaint was processed accordingly for the device.No medically significant information was added.No further changes were done to the case.Update 11jul2018: updated medwatch fields for expedited device reporting.No new information added.Update 23jul2018: upon review of the information received on 02-jul-2018, lot number and product compliant number were added in narrative.The narrative was updated.No new information added.Edit 25jul2018: upon internal review on 25jul2018 of information received 26jun2018, removed suspect insulin lispro since formulation and lilly insulin was not reported, changed as reported term of blood glucose increased to blood glucose unstable (fluctuation), changed as reported term blood glucose decreased to blood glucose falls and could not decrease, added non serious spike in blood glucose, and updated narrative to reflect changes.Edit 25jul2018: 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 dated 26jul2018 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported the injection button of her humapen ergo ii "could not press down." the patient experienced decreased and increased blood glucose.The device was not returned for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.The patient indicated the device was obtained 10 years ago.The humapen user manuals indicate the timeframe for which a device model has been designed to be used.Ten (10) years exceeds the timeframe for any humapen model.There is evidence of improper use.The patient used the device beyond its approved use life.It is unknown if this is relevant to the events of decreased and increased blood glucose levels.
 
Event Description
Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 68-year-old asian female patient.Medical history was not provided.Concomitant medication included metformin and acarbose both used for the treatment of diabetes.The patient received an unspecified lilly insulin (formulation unknown) via a reusable humapen ergo ii pen subcutaneously at a dose of 22 units in the morning and 20 units at night for the treatment of diabetes beginning on an unknown date (reported as over ten years).On an unknown date, while on an unspecified insulin, she was hospitalized due to her blood glucose levels were unstable; no further hospitalization details were provided.After the hospitalization, the patient was switched to insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) subcutaneously via humapen ergo ii device at a dose of 26 units in morning, 24 units in night for the treatment of diabetes beginning on an unknown date in the year 2015.After the switch, her blood glucose still could not be decreased, further described as had intense spikes and falls.On an unknown date, she also received acetylsalicylic acid (aspirin) which was used for the treatment of unknown indication beginning on an unknown date.Dose, route of administration, indication, and frequency were not provided.On an unknown date in (b)(6) 2017, she had ocular fundus bleeding and she was not able to see clearly.On an unknown date in (b)(6) 2017, an eye laser surgery was done.The event of retinal hemorrhage was considered as serious due to its medical significance.On an unknown date in (b)(6) 2018 (noted as a several days prior to the initial report date), the injection button of her humapen ergo ii device could not be pushed down (product complaint (b)(4)/lot number unknown).It was also noted that the device was obtained ten years ago.No further information regarding corrective treatment was provided.Outcome of the events serious blood glucose fluctuation, non-serious blood glucose increased and blood glucose decreased were unknown; the retinal hemorrhage outcome was not recovered.Insulin lispro protamine suspension 75%/insulin lispro 25% treatment was continued.Status of acetylsalicylic acid was not provided.The user of the humapen ergo ii device was unknown and his/her training status was not provided.The general device duration was not provided.The suspect device duration of use was over ten years.The suspect device, with (b)(4) was not returned to the manufacturer.The initial reporting consumer considered that the event of blood glucose unstable, blood glucose decreased, and blood glucose increased as related to diet and exercise, not suspect drug.The retinal haemorrhage was not related to insulin lispro protamine suspension 75%/insulin lispro 25% treatment but related to taking acetylsalicylic acid.The event of retinal haemorrhage was related to acetylsalicylic acid.The initial reporting consumer did not provide the relatedness of the events with the humapen ergo ii device.Update 05-jul-2018: additional information received on 02-jul-2018.Product complaint number was received and product complaint was processed accordingly for the device.No medically significant information was added.No further changes were done to the case.Update 11jul2018: updated medwatch fields for expedited device reporting.No new information added.Update 23jul2018: upon review of the information received on 02-jul-2018, lot number and product compliant number were added in narrative.The narrative was updated.No new information added.Edit 25jul2018: upon internal review on 25jul2018 of information received 26jun2018, removed suspect insulin lispro since formulation and lilly insulin was not reported, changed as reported term of the serious blood glucose increased to blood glucose unstable (fluctuation), changed as serious reported term blood glucose decreased to non-serious blood glucose falls and could not decrease, added non serious spike in blood glucose (blood glucose increased), and updated narrative to reflect changes.Edit 25jul2018: updated medwatch fields for expedited device reporting.No new information added.Update 26jul2018: additional information received on 24jul2018 and 25jul2018 from the global product complaint database which were processed together.Recoded suspect device from humapen (unknown) to humapen ergo ii.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information, reiterated improper use and storage of yes, and device return status to not returned to manufacturer for (b)(4) associated with an unknown lot of a humapen ergo ii device.Clarified the serious/non-serious event changes in the above update statement.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 Key7719549
MDR Text Key115061904
Report Number1819470-2018-00112
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 08/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Was Device Available for Evaluation? No
Date Manufacturer Received07/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age68 YR
Patient Weight70
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