Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9557
Device Problems Fluid/Blood Leak (1250); Activation, Positioning or Separation Problem (2906)
Patient Problem Complaint, Ill-Defined (2331)
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred.A follow-up report will be submitted when the final evaluation is completed as necessary.This report is associated with 1819470-2020-00060 and 1819470-2020-00061 since there is more than one device implicated.
 
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, concerned a (b)(6) year-old (at the time of initial report) male patient of (b)(6) origin.Medical history included high blood pressure.Concomitant medications included ka bo ping (as reported) for the treatment of unknown indication.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from a cartridge via humapen ergo ii reusable device (blue, plastic), morning 30-40 units, night 20-30 units, subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date.After several years of the use, he was hospitalized to regulate blood sugar.On an unknown date in 2013 or 2014 he finished/ stopped using human insulin mix 70/30.After several years of the use of human insulin mix 70/30, when he was hospitalized to regulate blood sugar, and then he changed to use insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix 50, 100 u/ml) from a cartridge via a humapen ergo ii reusable device (blue, plastic) (whether to change to insulin humalog mix 50 according to the doctor instructions was not obtained).After changing to insulin lispro mix 50, he was hospitalized every year to regulate blood sugar and check his body.On an unknown date the injection button of the first humapen ergo ii device (blue, plastic) pressed down sometimes or not sometimes (b)(4), lot number unknown).On an unknown date the first humapen ergo ii device had been replaced.On an unknown date the injection button of the second humapen ergo ii device (blue, plastic) could be pressed down sometimes or not sometimes (b)(4) , lot number unknown).On an unknown date the second humapen ergo ii device had been replaced.On an unknown date in 2018 he received third humapen ergo ii device.On an unknown date in end of the (b)(6) 2020, the injection button of the humapen (blue, plastic) could be pressed down sometimes or not.Insulin leaked out from the red plunger of the humapen ergo ii device (b)(4), lot number 1405d01).On (b)(6) 2020 he was hospitalized because of a rise in blood sugar, and the situation had improved currently (as of (b)(6) 2020).Information regarding corrective treatment was not provided.Outcome of the events was recovering.Status of human insulin mix 70/30 was discontinued and it was unknown if it would be restarted.Status of the insulin lispro mix 50 therapy was ongoing.The patient was the operator of the reusable humapen ergo ii devices and his training status was not provided.The general device model duration of use and suspect device duration of use for the first and second humapen ergo ii devices was unknown.The general device model duration of use and suspect device duration of use for the third humapen ergo ii device was unknown but started about 2018.The action taken with suspect reusable humapen ergo ii devices was unknown.The status of suspect reusable humapen ergo ii devices was unknown and their return status was not provided.The initial reporting consumer did not know if the events were related to human insulin mix 70/30 drug and insulin lispro mix 50 drug.The initial reporting consumer did not provide relatedness assessment between the events and humapen ergo ii devices.Update 21may2020: additional information received on 21may2020 from global product complaint database.Changed the lot number from unknown to 1405d01 for product complaint (b)(4) relating to the humapen ergo ii device.Corresponding fields and narrative updated accordingly.Edit 21may2020: updated medwatch and (b)(6) 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 a consumer who contacted the company to report adverse events and product complaint, concerned a 60-year-old (at the time of initial report) male patient of asian (han) origin.Medical history included high blood pressure.Concomitant medications included ka bo ping (as reported) for the treatment of unknown indication.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from a cartridge via humapen ergo ii reusable device (blue, plastic), morning 30-40 units, night 20-30 units, subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date.After several years of the use, he was hospitalized to regulate blood sugar.On an unknown date in 2013 or 2014 he finished/ stopped using human insulin mix 70/30.After several years of the use of human insulin mix 70/30, when he was hospitalized to regulate blood sugar, and then he changed to use insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix 50, 100 u/ml) from a cartridge via a humapen ergo ii reusable device (blue, plastic) (whether to change to insulin humalog mix 50 according to the doctor instructions was not obtained).After changing to insulin lispro mix 50, he was hospitalized every year to regulate blood sugar and check his body.On an unknown date the injection button of the first humapen ergo ii device (blue, plastic) pressed down sometimes or not sometimes ((b)(4), lot number unknown).On an unknown date the first humapen ergo ii device had been replaced.On an unknown date the injection button of the second humapen ergo ii device (blue, plastic) could be pressed down sometimes or not sometimes ((b)(4) , lot number unknown).On an unknown date the second humapen ergo ii device had been replaced.On an unknown date in 2018 he received third humapen ergo ii device.On an unknown date in end of the (b)(6) 2020, the injection button of the humapen (blue, plastic) could be pressed down sometimes or not.Insulin leaked out from the red plunger of the humapen ergo ii device ((b)(4), lot number 1405d01).On (b)(6) 2020 he was hospitalized because of a rise in blood sugar, and the situation had improved currently (as of (b)(6) 2020).Information regarding corrective treatment was not provided.Outcome of the events was recovering.Status of human insulin mix 70/30 was discontinued and it was unknown if it would be restarted.Status of the insulin lispro mix 50 therapy was ongoing.The patient was the operator of the reusable humapen ergo ii devices and his training status was not provided.The general device model duration of use and suspect device duration of use for the first and second humapen ergo ii devices was unknown.The general device model duration of use and suspect device duration of use for the third humapen ergo ii device was unknown but started about 2018.The action taken with suspect reusable humapen ergo ii devices was unknown.The status of suspect reusable humapen ergo ii devices was unknown and their return status was not provided.The initial reporting consumer did not know if the events were related to human insulin mix 70/30 drug and insulin lispro mix 50 drug.The initial reporting consumer did not provide relatedness assessment between the events and humapen ergo ii devices.Update 21may2020: additional information received on 21may2020 from global product complaint database.Changed the lot number from unknown to 1405d01 for product complaint (b)(4) relating to the humapen ergo ii device.Corresponding fields and narrative updated accordingly.Edit 21may2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 11-jun-2020: upon review of the information received on 18-may-2020, the device age for the third humapen ergo ii was added in the tab as well as in narrative.No other changes were made to the case.Update 15jun2020: additional information received on 15jun2020 from the global product complaint database.Entered device specific safety summaries (dsss) for the humapen ergo ii devices associated with product complaints (b)(4).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information for the suspect humapen ergo ii devices associated with product complaint (b)(4), which were not returned to the manufacturer.Updated the medwatch fields with device information and the european and canadian (eu/ca) device information, malfunction from unknown to no, and device return status to returned to manufacturer for the suspect humapen ergo ii device associated with product complaint (b)(4).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 15jun2020 in the b.5.Field.This report is associated with 1819470-2020-00060 and 1819470-2020-00061 since there is more than one device implicated.No further follow-up is planned.Evaluation summary: a male patient reported that, on an unknown date, the injection button of his humapen ergo ii "could be pressed down sometimes or not sometimes." on an unknown date, he experienced increased and abnormal blood glucose.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 ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.There is no evidence of improper use or storage.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10097129
MDR Text Key195450976
Report Number1819470-2020-00062
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 06/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2020
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Device Model NumberMS9557
Was Device Available for Evaluation? No
Date Manufacturer Received06/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age60 YR
Patient Weight66
-
-