MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES

Model Number MS9557

Device Problems Break (1069); Fluid/Blood Leak (1250); Failure to Deliver (2338); Inaccurate Delivery (2339); Difficult or Delayed Activation (2577); Mechanical Jam (2983)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Hold gn 11-19 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 product complaint (pc), concerned a (b)(6) (at the time of initial report) asian male patient.There were no medical history and concomitant medications.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml), through cartridge via humapen ergo ii, (morning 14, night 12; twice a day) subcutaneously for the treatment of diabetes mellitus beginning on an unknown date in 2016-2018.She started humapen ergo ii device in 2015.On an unknown date, while on human insulin isophane suspension 70%/human insulin 30% therapy, because the blood glucose was not controlled well, it was fluctuating as it was suddenly high and suddenly low (blood glucose was 17,18 when it was high, low blood glucose value was not provided).Changed the injection dose by self from prescribed dose (morning 14, night 12) to injected morning 16, night 14 when blood glucose was low, and injected morning 18, night 14 when blood glucose was high.On unknown dates, several times he passed out (fainted) during sleeping when blood glucose was low.He experienced loss of consciousness for three to four times at night when got up to urinate (specific dates were unknown).For the first and second time, he was sent to hospital by family member, and the blood glucose value was measured at 2-3 (no units were provided) at the hospital, the doctor said it was caused by hypoglycemia and made him to take some food.When the loss of consciousness occurred, he also developed trembling.He thought the hypoglycemia might be caused by the dose injected in the evening was too much (14 units) or eating less in dinner.The hypoglycemia, blood glucose decreased, trembling and passed out were considered as symptom associated with the diagnosis of hypoglycemic unconsciousness.Since an unknown date, he could not fall asleep and due to that the weight was decreased, it was (b)(6) before when it was normal, then it became (b)(6).Since an unknown date, the eyes could not see clearly, and it was caused by diabetes.On (b)(6) 2020 or (b)(6) 2020, the humapen ergo ii syringe had two drops of liquid leakage before injection and it was jammed when injecting, sometimes the injection button of the humapen ergo ii could not be pressed in the middle of injection ((b)(4), lot 1404d01).During injection, the injection button of the humapen ergo ii was stuck when he tried to press in the last two to three days.He changed insulin needle once for every two insulin cartridges and he kept his insulin pen with needle inside the fridge (it was considered as improper use of the humapen ergo ii).Because the insulin syringe was broken, so he suspected the injection dose was inaccurate.On (b)(6) 2021, because of the issue of problem of the insulin injection pen ((b)(4), lot 1404d01), the patient did not inject in the humulin 70/30 insulin for several consecutive days from (b)(6) 2021.It caused the complication disease.Because of the ketoacidosis, the patient was sent to the hospital for emergency on (b)(6) 2021, the blood glucose was high up to 38.9, hospitalized for half a month.After hospitalization, it was changed to using humalog series insulin according to the doctor's advice.Corrective treatments were not reported.Outcome of the event blood glucose fluctuation was recovering, event could not fall asleep was not recovered, while outcome of remaining events was unknown.Therapy with human insulin isophane suspension 70%/human insulin 30% was discontinued.The operator of the humapen ergo ii was patient and his training status was not provided.The general humapen ergo ii model duration of use was not provided.Suspect humapen ergo ii duration of use was approximately four years as it started approximately in 2015-2016.The suspect humapen ergo ii device associated with (b)(4) was not returned to the manufacturer.The suspect humapen ergo ii device associated with (b)(4) was returned to the manufacturer.The reporting consumer related the event of hypoglycemic unconsciousness to human insulin isophane suspension 70%/human insulin 30% therapy and did not know if the remaining events were related to human insulin isophane suspension 70%/human insulin 30% therapy.The reporting consumer related the event of inaccurate dose, missed dose to humapen ergo ii devices while did not provide relatedness of the remaining events to humapen ergo ii.Edit 30-jun-2020: upon review of information received on 17-jun-2020, as determined causality has been updated for the event of weight decreased to no.No other changes has been made to the case.Update 01-jul-2020: additional information received from global product complaint department on 23-jun-2020 and 30-jun-2020 were processed together on the same date.Added a new non-serious event of blood glucose fluctuation (removed the event of blood glucose high), updated the non-serious event of blood glucose low to serious and updated its outcome to unknown, updated listedness of the event passed out, updated operator of device.Updated eu/ca fields and narrative with new information.Update 06-jul-2020: additional information was received from initial reporter on 01-jul-2020.Added laboratory data and serious event of hypoglycemic unconsciousness (the events of blood glucose decreased and passed out were subsumed as the diagnosis was reported).Updated the causality statement and narrative with new information.Upon review of the case, added the age of the suspect humapen ergo ii.Edit 08jul2020: updated medwatch and (b)(4) fields for expedited device reporting.No new information added.Update 06aug2020: additional information received on 04aug2020 and 06aug2020 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 (b)(6) (eu/(b)(6)) device information, and malfunction from unknown to no.Added date of manufacturer for the suspect humapen ergo ii device associated with product complaint (b)(6), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.Update 16-sep-2021: additional information received from initial reporter on 13-sep-2021 via psp.Added serious events of blood glucose increased, ketoacidosis and non-serious event of missed dose.Added lab data, dosage regimen, action taken and narrative accordingly.Edit 24-sep-2021: upon review of information received on 13-sep-2021 and additional information received from the global product complaint database15-sep-2021.Added new humapen ergo ii suspect device of same lot 1404d01 to process (b)(6), updated corresponding fields and narrative accordingly.Edit 07oct2021: updated medwatch and (b)(4) fields for expedited device reporting.No new information added.

Manufacturer Narrative

Investigation in progress.A follow-up report will be submitted when the final evaluation is completed.

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 28oct2021 in the b.5.Field.No further follow- up is planned.This report is associated with 1819470-2020-00081 since there is more than one device implicated.Evaluation summary: a male patient reported that the injection button of a humapen ergo ii could be pushed down on (b)(6) 2021, the injection screw could move but no insulin flowed out.The patient did not inject insulin due to the injection pen issue for several consecutive days since (b)(6) 2021.The patient experienced hypoglycemic unconsciousness, ketoacidosis, and increased blood glucose.The investigation of the returned device (batch 1404d01, manufactured april 2014) found the device met functional requirements.No malfunction was identified.The patient reported that he had used the device since 2015 (six 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.The core instructions for use also to always carry a spare insulin pen in case your pen is lost or damaged.There is evidence of improper use.The patient used the device beyond the recommended use period.This misuse may not be relevant to this complaint or to the events of hypoglycemic unconsciousness, ketoacidosis, and increased blood glucose, since the device met functional requirements.

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 product complaint (pc), concerned a 61 year old (at the time of initial report) asian male patient.There were no medical history and concomitant medications.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml), through cartridge via humapen ergo ii, (morning 14, night 12; twice a day) subcutaneously for the treatment of diabetes mellitus beginning on an unknown date in 2016 to 2018.She started humapen ergo ii device in 2015.On an unknown date, while on human insulin isophane suspension 70%/human insulin 30% therapy, because the blood glucose was not controlled well, it was fluctuating as it was suddenly high and suddenly low (blood glucose was 17,18 when it was high, low blood glucose value was not provided).Changed the injection dose by self from prescribed dose (morning 14, night 12) to injected morning 16, night 14 when blood glucose was low, and injected morning 18, night 14 when blood glucose was high.On unknown dates, several times he passed out (fainted) during sleeping when blood glucose was low.He experienced loss of consciousness for three to four times at night when got up to urinate (specific dates were unknown).For the first and second time, he was sent to hospital by family member, and the blood glucose value was measured at 2 to 3 (no units were provided) at the hospital, the doctor said it was caused by hypoglycemia and made him to take some food.When the loss of consciousness occurred, he also developed trembling.He thought the hypoglycemia might be caused by the dose injected in the evening was too much (14 units) or eating less in dinner.The hypoglycemia, blood glucose decreased, trembling and passed out were considered as symptom associated with the diagnosis of hypoglycemic unconsciousness.Since an unknown date, he could not fall asleep and due to that the weight was decreased, it was 64kg before when it was normal, then it became 61.5kg to 62kg.Since an unknown date, the eyes could not see clearly, and it was caused by diabetes.On (b)(6) 2020 or (b)(6) 2020, the humapen ergo ii syringe had two drops of liquid leakage before injection and it was jammed when injecting, sometimes the injection button of the humapen ergo ii could not be pressed in the middle of injection ((b)(4), lot 1404d01).During injection, the injection button of the humapen ergo ii was stuck when he tried to press in the last two to three days.He changed insulin needle once for every two insulin cartridges and he kept his insulin pen with needle inside the fridge (it was considered as improper use of the humapen ergo ii).Because the insulin syringe was broken, so he suspected the injection dose was inaccurate.On (b)(6) 2021, because of the issue of problem of the insulin injection pen ((b)(4); lot 1404d01), the patient did not inject in the humulin 70/30 insulin for several consecutive days from (b)(6) 2021.It caused the complication disease.Because of the ketoacidosis, the patient was sent to the hospital for emergency on (b)(6) 2021, the blood glucose was high up to 38.9, hospitalized for half a month.After hospitalization, it was changed to using humalog series insulin according to the doctors advice.Corrective treatments were not reported.Outcome of the event blood glucose fluctuation was recovering, event could not fall asleep was not recovered, while outcome of remaining events was unknown.Therapy with human insulin isophane suspension 70%/human insulin 30% was discontinued.The operator of the humapen ergo ii was patient and his training status was not provided.The general humapen ergo ii model duration of use was not provided.Suspect humapen ergo ii associated with (b)(4) duration of use was approximately four years and it was not returned to the manufacturer.The suspect humapen ergo ii device associated with (b)(4) had been used since 2015 (approximately six years considered as improper use) and was returned to the manufacturer on 15sep2021.The reporting consumer related the event of hypoglycemic unconsciousness to human insulin isophane suspension 70%/human insulin 30% therapy and did not know if the remaining events were related to human insulin isophane suspension 70%/human insulin 30% therapy.The reporting consumer related the event of inaccurate dose, missed dose to humapen ergo ii devices while did not provide relatedness of the remaining events to humapen ergo ii.Edit 30-jun-2020: upon review of information received on 17jun2020, as determined causality has been updated for the event of weight decreased to no.No other changes has been made to the case.Update 01-jul-2020: additional information received from global product complaint department on 23-jun-2020 and 30-jun-2020 were processed together on the same date.Added a new non-serious event of blood glucose fluctuation (removed the event of blood glucose high), updated the non-serious event of blood glucose low to serious and updated its outcome to unknown, updated listedness of the event passed out, updated operator of device.Updated eu/ca fields and narrative with new information.Update 06jul2020: additional information was received from initial reporter on 01jul2020.Added laboratory data and serious event of hypoglycemic unconsciousness (the events of blood glucose decreased and passed out were subsumed as the diagnosis was reported).Updated the causality statement and narrative with new information.Upon review of the case, added the age of the suspect humapen ergo ii.Edit 08jul2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 06aug2020: additional information received on 04aug2020 and 06aug2020 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, and malfunction from unknown to no.Added date of manufacturer for the suspect humapen ergo ii device associated with product complaint (b)(4), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.Update 16sep2021: additional information received from initial reporter on 13sep2021 via psp.Added serious events of blood glucose increased, ketoacidosis and nonserious event of missed dose.Added lab data, dosage regimen, action taken and narrative accordingly.Edit 24sep2021: upon review of information received on 13sep2021 and additional information received from the global product complaint database15-sep-2021.Added new humapen ergo ii suspect device of same lot 1404d01 to process (b)(4), updated corresponding fields and narrative accordingly.Edit 07oct2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 28oct2021: additional information received on 22oct2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) with device information, malfunction from unknown to no, device return status to returned to manufacturer and added date of manufacturer for suspect humapen ergo ii device (lot 1404d01) associated with (b)(4).Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): TECH GROUP NORTH AMERICA INC. DBA WEST; 640 south rockford drive; tempe AZ 85281
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 12625425
• MDR Text Key: 281016778
• Report Number: 1819470-2021-00135
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 1404D01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2021
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian