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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 No Flow (2991)
Patient Problem Hyperglycemia (1905)
Event Date 01/31/2016
Event Type  Injury  
Manufacturer Narrative
Device not returned.Usage concerns resolved, and device was reported to be working properly.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 complaint (pc), concerned a (b)(6) years old male patient of (b)(6) nationality.Medical history(complicating disease, allergic history, family medical history) and family drug adverse reaction were none.Previous drug adverse reaction included antiphlogistic drug (sulfanilamide tablets).Concomitant medication included acarbose for unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 25, 100u/ml) from cartridge via reusable device (humapen ergo ii), at unknown dose twice daily, subcutaneously, for the treatment of diabetes mellitus, from around 2014.On an unknown date in 2016, after starting insulin lispro protamine suspension 75%/insulin lispro 25% therapy, the humapen ergo ii injection screw could not move, the injection button could be pushed down but the medicine could not flow out (pc 5150546/ lot number unknown).The injection dose administered was a little less, resulting in poor blood sugar control (high blood sugar, no values and reference ranges were provided.He was hospitalised due high blood sugars (no more details regarding dates as well as treatment and laboratory tests done while hospitalized were provided).Reportedly, the new needle was not changed for every injection (improper use of device).On an unknown date, his ear was not very good and could not hear clearly was aggravated.Information regarding corrective treatment and outcome for the events was not provided.Insulin lispro protamine suspension 75%/insulin lispro 25% was ongoing.The operator of the humapen ergo ii and his/her training status were not provided.The humapen ergo ii model duration of use was not provided.The suspect humapen ergo ii duration of use was two years at the time of event as it was started in 2014.The use of the suspect humapen ergo ii was continued as the usage concern was resolved and its return was not expected.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/insulin lispro 25% therapy.The reporting consumer related the events of high blood sugar and incomplete dose administered with humapen ergo ii issue and did not provide a relatedness assessment for the remaining event to humapen ergo ii.Update 19-may-2020: both the information received on 14-may-2020 were processed together.Edit 21may2020: updated medwatch and (b)(4) (eu/ca) fields for expedited device reporting.No new information added.
 
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 79 years old male patient of han nationality.Medical history(complicating disease, allergic history, family medical history) and family drug adverse reaction were none.Previous drug adverse reaction included antiphlogistic drug (sulfanilamide tablets).Concomitant medication included acarbose for unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 25, 100u/ml) from cartridge via reusable device (humapen ergo ii), at unknown dose twice daily, subcutaneously, for the treatment of diabetes mellitus, from around 2014.On an unknown date in 2016, after starting insulin lispro protamine suspension 75%/insulin lispro 25% therapy, the humapen ergo ii injection screw could not move, the injection button could be pushed down but the medicine could not flow out (pc 5150546/ lot number unknown).The injection dose administered was a little less, resulting in poor blood sugar control (high blood sugar, no values and reference ranges were provided.He was hospitalised due high blood sugars (no more details regarding dates as well as treatment and laboratory tests done while hospitalized were provided).Reportedly, the new needle was not changed for every injection (improper use of device).It was noted after being hospitalized the patient adjusted the injection dose (morning 20, night 18) following advice of doctor.On an unknown date, his ear was not very good and could not hear clearly was aggravated.Information regarding corrective treatment and outcome for the events was not provided.Insulin lispro protamine suspension 75%/insulin lispro 25% was ongoing.The operator of the humapen ergo ii and his/her training status were not provided.The humapen ergo ii model duration of use was not provided.The suspect humapen ergo ii duration of use was two years at the time of event as it was started in 2014.The use of the suspect humapen ergo ii was continued as the usage concern was resolved.The suspect humapen ergo ii device associated with product complaint 5150546 was not returned to the manufacturer.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/insulin lispro 25% therapy.The reporting consumer related the events of high blood sugar and incomplete dose administered with humapen ergo ii issue and did not provide a relatedness assessment for the remaining event to humapen ergo ii.Update (b)(6) 2020: both the information received on (b)(6) 2020 were processed together.Edit (b)(6) 2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update (b)(6) 2020: additional information received on (b)(6) 2020 from the global product complaint database.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 for the suspect humapen ergo ii device associated with product (b)(4), which was not returned to the manufacturer.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 (b)(6) 2020 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient reported that the injection screw of his humapen ergo ii device could not move, the injection button could be pushed down, but no medicine flowed out.He also reported "the injection dose administered was a little less." the patient experienced increased blood glucose.The device was not returned for investigation (batch unknown).With the guidance of a trained professional; troubleshooting was performed and the issue was resolved.All humapen ergo ii 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 reported reusing needles.The core instructions for use states to use a new needle for each injection.There is evidence of improper use.The patient reused needles.This misuse may be relevant to the complaint of injection screw not moving.It is unknown if the misuse is relevant to 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 46285
MDR Report Key10092384
MDR Text Key195378058
Report Number1819470-2020-00058
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 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2020
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 Received06/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age79 YR
Patient Weight62
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