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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO; FOR TREATMENT PURPOSES
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ELI LILLY AND COMPANY HUMAPEN ERGO; FOR TREATMENT PURPOSES Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoglycemia (1912); Coma (2417)
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 1819470-2019-00173 and 1819470-2019-00174 since there is more than one device implicated.
 
Event Description
(b)(4).This report is associated with product complaint: pending.This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6)-year-old female patient of unknown origin.Medical history was not provided.Concomitant medications included unspecified hypertension medications and unspecified medications for thyroid disease.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injection (humulin 70/30), unknown formulation via a reusable device humapen ergo unknown body type, subcutaneously, for the treatment of diabetes mellitus, beginning approximately in 2015 or 2016.On an unknown date, 5-6 months after using humapen ergo unknown body type, it was not able to release insulin as its screw got stuck and possibly missed the dose and had hyperglycemic coma (pc pending/lot unknown).Since an unknown date, she started receiving human insulin isophane suspension 70%/human insulin 30% treatment via a humapen savvio pink which was spoiled in the same way after few months, and possibly had missed the dose due to pen issue and had hyperglycemic coma ((b)(4)/lot unknown).Approximately on (b)(6) 2019, she took human insulin isophane suspension 70%/human insulin 30% treatment via a humapen ergo unknown body type which was spoiled in the same way after one time use (one dose) and possibly had missed the dose due to pen issue and had hyperglycemic coma ((b)(4)/lot unknown).The event of hyperglycemic coma was considered as serious due to its medical significance.She had recovered from the events.Corrective treatment was not provided.As of (b)(6) 2019, treatment with human insulin isophane suspension 70%/human insulin 30% was continued.The operator of humapen ergo unknown body type (both devices) and humapen savvio pink and his/her training status was not provided.The general model humapen ergo unknown body type (both devices) and humapen savvio pink duration of use was not provided.The suspect humapen ergo unknown body type (first device) duration of use was approximately six months as started approximately in 2015 or 2016.The suspect humapen ergo unknown body type (second device) was one day and humapen savvio pink duration of use was not provided.The status of humapen ergo unknown body type (both devices) and humapen savvio pink was discontinued and their return was expected.The initial reporting consumer did not relate the events with human insulin isophane suspension 70%/human insulin 30% treatment.The initial reporting consumer related the events with product complaint associated with humapen ergo unknown body type (both devices) and humapen savvio pink.Update 13-sep-2019: all the documents received on 09-sep-2019 were processed at same time.Edit 25sep2019: updated medwatch fields for expedited device reporting.No new information added.Edit 02oct2019: updated medwatch fields for expedited device reporting.No new information added.Edit 02oct2019: 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 29oct2019 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2019-00173 and 1819470-2019-00174 since there is more than one device implicated.Evaluation summary: a female patient reported that the injection screw of her humapen ergo was stuck and would not release insulin.She experienced diabetic hyperglycemic coma.The device was not returned to the manufacturer for investigation (batch number 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.There is no evidence of improper use or storage.
 
Event Description
Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 46-year-old female patient of unknown origin.Medical history was not provided.Concomitant medications included unspecified hypertension medications and unspecified medications for thyroid disease.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injection (humulin 70/30), unknown formulation via a reusable device humapen ergo unknown body type, subcutaneously, for the treatment of diabetes mellitus, beginning approximately in 2015 or 2016.On an unknown date, 5-6 months after using humapen ergo unknown body type, it was not able to release insulin as its screw got stuck and possibly missed the dose and had hyperglycemic coma (product complaint: (b)(4)/lot: unknown).Since an unknown date, she started receiving human insulin isophane suspension 70%/human insulin 30% treatment via a humapen savvio pink which was spoiled in the same way after few months, and possibly had missed the dose due to pen issue and had hyperglycemic coma (product complaint: (b)(4)/lot unknown).Approximately on (b)(6) 2019, she took human insulin isophane suspension 70%/human insulin 30% treatment via a humapen ergo unknown body type which was spoiled in the same way after one time use (one dose) and possibly had missed the dose due to pen issue and had hyperglycemic coma (product complaint: (b)(4)/lot: unknown).The event of hyperglycemic coma was considered as serious due to its medical significance.She had recovered from the events.Corrective treatment was not provided.As of on (b)(6) 2019, treatment with human insulin isophane suspension 70%/human insulin 30% was continued.The operator of humapen ergo unknown body type (both devices) and humapen savvio pink and his/her training status was not provided.The general model humapen ergo unknown body type (both devices) and humapen savvio pink duration of use was not provided.The suspect humapen ergo unknown body type (associated with (b)(4) duration of use was approximately six months.The suspect humapen savvio pink duration of use was not provided (noted to be spoiled after a few months).The suspect humapen ergo unknown body type (associated with (b)(4) duration of use was one day.The status of humapen ergo unknown body type (both devices) and humapen savvio pink was discontinued and their return was expected.However, none of the devices were returned to the manufacturer.The initial reporting consumer did not relate the events with human insulin isophane suspension 70%/human insulin 30% treatment.The initial reporting consumer related the events with product complaint associated with humapen ergo unknown body type (both devices) and humapen savvio pink.Update 13-sep-2019: all the documents received on 09-sep-2019 were processed at same time.Edit 25sep2019: updated medwatch fields for expedited device reporting.No new information added.Edit 02oct2019: updated medwatch fields for expedited device reporting.No new information added.Edit 02oct2019: updated medwatch fields for expedited device reporting.No new information added.Update 29oct2019: additional information received on 25oct2019 from the global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information for the suspect humapen ergo (unknown pen body type) device associated with product complaint: (b)(4), the suspect humapen savvio (pink) device associated with product complaint: (b)(4), and the suspect humapen ergo (unknown pen body type) device associated with product complaint: (b)(4); none of which were returned to the manufacturer.Corresponding fields and narrative updated accordingly.
 
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Brand Name
HUMAPEN ERGO
Type of Device
FOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
MDR Report Key9151594
MDR Text Key166594992
Report Number1819470-2019-00175
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K982842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 10/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
Is this an Adverse Event Report? Yes
Device Operator Other
Device Model NumberUNKNOWN
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age46 YR
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