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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 Activation, Positioning or Separation Problem (2906)
Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Visual Impairment (2138); Dizziness (2194); Sleep Dysfunction (2517); Missed Dose (2561)
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)(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 complaints (pc), concerned a (b)(6) years old female patient of (b)(6) nationality.Medical history (comorbidity, allergy history, family history) and previous medical history included eyes not good, hypertension, kidney disease and cerebral blood point (as reported).Family history included hypertension.Allergy history included sulfonamide allergy.Previous drug adverse reaction and family drug reaction were unknown.Concomitant medication included metformin for diabetes mellitus.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from cartridge via reusable device (humapen ergo ii), twice daily (36 units in morning and 28 units at night), subcutaneously, for the treatment of diabetes mellitus, from second half of 1999.On an unknown date, after starting human insulin isophane suspension 70%/human insulin 30% therapy, she had occurred complication of eyes not good (improper use of the device), hypertension (high blood pressure, no values and reference ranges were provided) and kidney disease (nephropathy).Reportedly, on an unknown date, the injection button of the first humapen ergo ii could not be pushed down and the human insulin isophane suspension 70%/human insulin 30% could not flow out (b)(4), lot number 1110d02) and she would change the injection pen needle every three days (improper use of the device).She also experienced dizziness, inability to see, could not sleep and high blood glucose (fasting blood glucose at 15-16, no units and reference ranges were provided).In (b)(6) 2016, she was hospitalized due to dizziness, inability to see, could not sleep and high fasting blood glucose.During the period of hospitalization, she experienced penicillin, potassium allergy and her arm could not move (the event of arm could not move was considered serious due to medical significance).Her dose was changed from 36 in the morning and 28 in the evening to 40 in the morning and 32 in the evening according by advice of the doctor during the period of hospitalization.She was discharged after 21 days.The situation of dizziness, inability to see, could not sleep and high blood glucose (fasting blood glucose at 15-16) was recovering.The situations of penicillin, potassium allergy and arm could not move had not become recovering until half a year later in (b)(6) 2017.In (b)(6) 2019, she started a new humapen ergo ii.The injection button of this humapen ergo ii could not be pushed down and the human insulin isophane suspension 70%/human insulin 30% could not flow out (the injection button could not be pressed if the humapen ergo ii had human insulin isophane suspension 70%/human insulin 30% installed and if not installed, it can be pressed).She had changed the needle and debugged by herself, but the medicine still could not be injected (b)(4), lot number 1809d01).Information regarding corrective treatment and outcome for the event of missed dose was not provided.She was recovering from the remaining events.Status of human insulin isophane suspension 70%/human insulin 30% therapy was ongoing.The patient was the operator of the humapen ergo ii and her training status was not provided.The humapen ergo ii model duration of use was not provided.The first suspect humapen model duration of use was not provided.The second suspect humapen ergo ii duration of use was eight months as it was started in (b)(6) 2019.The use of the first suspect humapen ergo ii was discontinued and the use of the second suspect humapen ergo ii was ongoing.The return status for both the suspect humapen ergo ii was not provided.The reporting consumer did not provide a relatedness assessment for the events to human insulin isophane suspension 70%/human insulin 30% therapy.The reporting consumer related the event of missed dose with the second suspect humapen ergo ii device issue and did not provide a relatedness assessment for the remaining events to both humapen ergo ii devices.Edit 13may2020: updated medwatch and (b)(6) fields for expedited device reporting.No new information added.Update 13-may-2020: upon internal review the medical history of cerebral blood point was added into the case.No medically significant information was provided.Narrative was updated accordingly.Update 18-may-2020: both the information was received from the initial reporting consumer on (b)(6) 2020 reiterating the previously reported information.No further changes were made to the case.
 
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 complaints (pc), concerned a 51 years old female patient of han nationality.Medical history (comorbidity, allergy history, family history) and previous medical history included eyes not good, hypertension, kidney disease and cerebral blood point (as reported).Family history included hypertension.Allergy history included sulfonamide allergy.Previous drug adverse reaction and family drug reaction were unknown.Concomitant medication included metformin for diabetes mellitus.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from cartridge via reusable device (humapen ergo ii), twice daily (36 units in morning and 28 units at night), subcutaneously, for the treatment of diabetes mellitus, from second half of 1999.On an unknown date, after starting human insulin isophane suspension 70%/human insulin 30% therapy, she had occurred complication of eyes not good (improper use of the device), hypertension (high blood pressure, no values and reference ranges were provided) and kidney disease (nephropathy).Reportedly, on an unknown date, the injection button of the first humapen ergo ii could not be pushed down and the human insulin isophane suspension 70%/human insulin 30% could not flow out ((b)(4), lot number 1110d02).It was noted she would change the injection pen needle every three days (improper use of the device).She also experienced dizziness, inability to see, could not sleep and high blood glucose (fasting blood glucose at 15-16, no units and reference ranges were provided).In (b)(6) 2016, she was hospitalized due to dizziness, inability to see, could not sleep and high fasting blood glucose.During the period of hospitalization, she experienced penicillin, potassium allergy and her arm could not move (the event of arm could not move was considered serious due to medical significance).Her dose was changed from 36 in the morning and 28 in the evening to 40 in the morning and 32 in the evening according by advice of the doctor during the period of hospitalization.She was discharged after 21 days.The situation of dizziness, inability to see, could not sleep and high blood glucose (fasting blood glucose at 15-16) was recovering.The situations of penicillin, potassium allergy and arm could not move had not become recovering until half a year later in (b)(6) 2017.In (b)(6) 2019, she started a new humapen ergo ii.The injection button of this humapen ergo ii could not be pushed down and the human insulin isophane suspension 70%/human insulin 30% could not flow out (the injection button could not be pressed if the humapen ergo ii had human insulin isophane suspension 70%/human insulin 30% installed and if not installed, it can be pressed).She had changed the needle and debugged by herself, but the medicine still could not be injected ((b)(4), lot number 1809d01).Information regarding corrective treatment and outcome for the event of missed dose was not provided.She was recovering from the remaining events.Status of human insulin isophane suspension 70%/human insulin 30% therapy was ongoing.The patient was the operator of the humapen ergo ii and her training status was not provided.The humapen ergo ii model duration of use was not provided.The first suspect humapen ergo ii duration of use was not provided.The second suspect humapen ergo ii duration of use was eight months as it was started in (b)(6) 2019.The humapen ergo ii device associated with (b)(4)(lot 1110d02) was returned to the manufacturer on 18may2020.The suspect humapen ergo ii associated with (b)(4)(lot 1809d01) would not be returned back to the manufacturer as use was ongoing.The reporting consumer did not provide a relatedness assessment for the events to human insulin isophane suspension 70%/human insulin 30% therapy.The reporting consumer related the event of missed dose with the second suspect humapen ergo ii (lot 1809d01) device issue and did not provide a relatedness assessment for the remaining events to both humapen ergo ii devices.Edit 13may2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 13-may-2020: upon internal review the medical history of cerebral blood point was added into the case.No medically significant information was provided.Narrative was updated accordingly.Update 18-may-2020: both the information was received from the initial reporting consumer on 13-may-2020 reiterating the previously reported information.No further changes were made to the case.Update 12jun2020: additional information received on 11jun2020 and 12jun2020 from the global product complaint database, which was processed together.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information, malfunction from unknown to yes/not cirm, and device return status to returned to manufacturer.Added date of manufacturer and date returned to manufacturer for the humapen ergo ii device associated with product complaint (b)(4).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 dated 12jun2020 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that the injection button of her humapen ergo ii device could not be pushed down and insulin could not flow out.The patient experienced increased blood glucose.The investigation of the returned device (batch 1110d02, manufactured october 2011) found the device displayed high injection force caused by unknown foreign material on multiple internal components of the device.There was damage/wear to the dialing screw threads likely caused by repeated patient use while the device exhibited high injection force.Due to the device damage, no further testing could be conducted.Malfunction confirmed.The foreign material was introduced in the field, not related to the manufacturing process.In addition, the patient likely continued to use the device while experiencing high injection force.The core instructions for use states that the injection button may become harder to push if the inside of the pen gets dirty with insulin, food, drink or other materials.Following the care and storage instructions should help prevent this.The patient reported visual impairment and changing the injection pen needle every three days.The core instructions for use states that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it.The core instructions for use also states to use a new needle for each injection.There is evidence of improper use.The foreign material contamination and damage to the device occurred while in the field (not related to the manufacturing process).The patient reused needles and used the device while visually impaired.These misuses may be relevant to the complaint and the event of increased blood glucose.
 
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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 Key10070572
MDR Text Key195100050
Report Number1819470-2020-00048
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 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Device Model NumberMS9557
Device Lot Number1110D02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2020
Initial Date Manufacturer Received 05/06/2020
Initial Date FDA Received05/19/2020
Supplement Dates Manufacturer Received06/11/2020
Supplement Dates FDA Received06/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age51 YR
Patient Weight85
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