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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 Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Complaint, Ill-Defined (2331)
Event Date 04/30/2019
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 an adverse event with a product complaint (pc), concerned an (b)(6) year-old asian female patient.The patients medical history was not provided.Concomitant medication included insulin glargine for unknown indication.The patient received insulin lispro (rdna origin) injection (humalog) cartridge via humapen ergo ii (lot number not provided), 10 iu in the morning, 10 iu at noon and 10 ui at night, subcutaneously, for the treatment of diabetes mellitus, beginning on an unspecified date reported on (b)(6) 2019 as at least over ten years ago.On an unspecified date, unknown time after starting the use of insulin lispro, the patients eyes were not good to use and her legs and foot were not good to use as well (as reported), which the reporter attributed to her old age.It was also provided the patient was hospitalized for six times (unknown dates) after she suffered from the disease (unspecified).In (b)(6) 2019, unknown time after starting the treatment with insulin lispro via humapen ergo ii, the patient presented high blood sugar and high blood pressure and due to both events she was hospitalized.No information was provided regarding exams, corrective treatment and outcome for the events.In (b)(6) 2019 or (b)(6) 2019 the humapen ergo ii was not working well but the reporting consumer was not able to provide further details (product complaint number (b)(4)/ lot number unknown).It was unknown if any action was taken with insulin lispro treatment due to the events and it was ongoing.Fu not possible as there was no response received after two attempts.It was unknown who operated the humapen ergo ii and if the operator was trained.The duration of use of the humapen ergo ii model and the suspect reported humapen ergo ii was between one and two years.The reported humapen ergo ii continued to be used and its return status was unknown.The reporting consumer did not know if the events were related to insulin lispro use and did not provide a relatedness assessment for the events to humapen ergo ii.Update 19nov2019: additional information received on 15nov2019 from affiliate was processed with initial report.Update 02-dec-2019: information was received from affiliate on 27-nov-2019 regarding unsuccessful follow up attempt.No medically significant changes were made to the case.Update 06-dec-2019: information was received on 04-dec-2019.Patient was called many times but did not pick the call.Lost to follow-up was added.No new medically significant information was added to the case.Edit.09dec2019: updated medwatch and european and (b)(6) (eu/(b)(6)) fielded 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 18dec2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that her humapen ergo ii device was not working well (specific issue unknown) in (b)(6) 2019.The patient experienced increased blood glucose in (b)(6) 2019.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 and dose accuracy with high probability.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 an adverse event with a product complaint (pc), concerned an 83-year-old asian female patient.The patients medical history was not provided.Concomitant medication included insulin glargine for unknown indication.The patient received insulin lispro (rdna origin) injection (humalog) cartridge via humapen ergo ii (lot number not provided), 10 iu in the morning, 10 iu at noon and 10 ui at night, subcutaneously, for the treatment of diabetes mellitus, beginning on an unspecified date reported on (b)(6) 2019 to be around 20 years ago or at least over ten years ago.On an unspecified date, unknown time after starting the use of insulin lispro, the patients eyes were not good to use and her legs and foot were not good to use as well (as reported), which the reporter attributed to her old age.It was also provided the patient was hospitalized for six times (unknown dates) after she suffered from the disease (unspecified).In (b)(6) 2019, unknown time after starting the treatment with insulin lispro via humapen ergo ii, the patient presented high blood sugar and high blood pressure and due to both events she was hospitalized.No information was provided regarding exams, corrective treatment and outcome for the events.In (b)(6) 2019 the humapen ergo ii was not working well but the reporting consumer was not able to provide further details product complaint number (b)(4), lot number unknown.It was unknown if any action was taken with insulin lispro treatment due to the events and it was ongoing.Follow-up not possible, as there was no response received after two attempts.It was unknown who operated the humapen ergo ii and if the operator was trained.The duration of use of the humapen ergo ii model and the suspect reported humapen ergo ii was between one and two years.The suspect humapen ergo ii device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not know if the events were related to insulin lispro use and did not provide a relatedness assessment for the events to humapen ergo ii.Update (b)(6)2019: additional information received on (b)(6) 2019 from affiliate was processed with initial report.Update (b)(6) 2019: information was received from affiliate on (b)(6) 2019 regarding unsuccessful follow up attempt.No medically significant changes were made to the case.Update (b)(6) 2019: information was received on (b)(6) 2019.Patient was called many times but did not pick the call.Lost to follow-up was added.No new medically significant information was added to the case.Edit.09dec2019: updated medwatch and european and canadian (eu/ca) fielded for expedited device reporting.No new information added.Update (b)(6) 2019: additional information received on (b)(6) 2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information 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.Upon review, entered suspect device age (device age field) accordingly.
 
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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 Key9450771
MDR Text Key185780599
Report Number1819470-2019-00215
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 01/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
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 Received12/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age83 YR
Patient Weight60
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