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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 Mechanical Problem (1384)
Patient Problem 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
Lilly case id: (b)(4).This report is associated with product compliant: (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) asian female patient.Medical history included high blood pressure, heart disease and diabetes mellitus.Historical drug included metformin, which caused stomachache.She did not receive any concomitant medications.The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) (humalog mix 50) via cartridge through a reusable humapen ergo ii, 24 u at morning and 16u at evening subcutaneously, twice daily for the treatment of diabetes mellitus, beginning in 2015-2016.On an unknown date in (b)(6) 2019, while on insulin lispro protamine suspension 50%/ insulin lispro 50%(insulin lispro 50/50) the injection button of a humapen ergo ii (blue, plastic) was difficult to be pushed down ((b)(4), lot-1601d03).She had been experiencing hypertension and hyperglycemia.On (b)(6) 2019, she was hospitalized for the cure of hypertension and hyperglycemia.No further information provided.Information regarding further corrective treatment, outcome of events was not provided.Insulin lispro 50/50 treatment status was continued.The operator of humapen ergo ii and his/her training status was unknown.The humapen ergo ii model duration of use and the suspect humapen ergo ii duration of use were four years.The action taken with the suspect device was not provided and its return was expected.The reporting consumer was not sure about any relatedness between events and insulin lispro 50/50 and did not provide the relatedness between events and humapen ergo ii.Update 25-apr-2019: initial information and follow-up information received on 22-apr-2019 was processed together.Edit 25apr2019: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting.No new information added.Update 03may2019: additional information received on 30apr2019 from global product complaint database.Changed the lot number from unknown to 1601d03 for product complaint (b)(4) relating to the humapen ergo ii device.Corresponding fields and narrative updated accordingly.
 
Manufacturer Narrative
Event: narrative field; new updated and corrected information is referenced within the update statements in event.Please refer to statement dated 29may2019 in the event field.This is a downgrade report, which no longer meets the criteria for expedited reporting.No further follow up is planned.Evaluation summary: a female patient reported that the injection button of her humapen ergo ii was difficult to push down.The patient experienced hyperglycemia.The investigation of the returned device (batch: 1601d03, manufactured january 2016) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.There is no evidence of improper use or storage.
 
Event Description
Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerned a 78-year-old asian female patient.Medical history included high blood pressure, heart disease and diabetes mellitus.Historical drug included metformin, which caused stomachache.She did not receive any concomitant medications.The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) (humalog mix 50) via cartridge through a reusable humapen ergo ii, 24 u at morning and 16u at evening subcutaneously, twice daily for the treatment of diabetes mellitus, beginning approximately in 2015-2016 (conflicting data).On an unknown date in mar-2019, while on insulin lispro protamine suspension 50%/ insulin lispro 50%(insulin lispro 50/50) the injection button of a humapen ergo ii (blue, plastic) was difficult to be pushed down (pc 4712616, lot number:1601d03).She had been experiencing hypertension and hyperglycemia.On (b)(6) 2019, she was hospitalized for the cure of hypertension and hyperglycemia.No further information provided.Information regarding further corrective treatment, outcome of events was not provided.Insulin lispro 50/50 treatment status was continued.The operator of humapen ergo ii and his/her training status was unknown.The humapen ergo ii model duration of use was not provided and the suspect humapen ergo ii duration of use was three years.The suspect device was returned to the manufacturer on 30apr2019.The reporting consumer was not sure about any relatedness between events and insulin lispro 50/50 and did not provide the relatedness between events and humapen ergo ii.Update 25-apr-2019: initial information and follow-up information received on 22-apr-2019 was processed together.Edit 25apr2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 03may2019: additional information received on 30apr2019 from global product complaint database.Changed the lot number from unknown to 1601d03 for product complaint: (b)(4) relating to the humapen ergo ii device.Corresponding fields and narrative updated accordingly.Update 29may2019: additional information received on 29may2019 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields, improper use and storage from yes to no, malfunction from unknown to no, device age from four to three years, and device return status to returned to manufacturer; added date of manufacture and date returned to manufacturer for the suspect device associated with pc 4712616.Corresponding fields and narrative updated accordingly.Edit 07jun2019: updated medwatch fields for expedited device reporting.No new information added.
 
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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 Key8621054
MDR Text Key145491521
Report Number1819470-2019-00087
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 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number1601D03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2019
Date Manufacturer Received05/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age78 YR
Patient Weight79
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