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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 Break (1069)
Patient Problems Infarction, Cerebral (1771); Fall (1848); High Blood Pressure/ Hypertension (1908); No Code Available (3191)
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 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) years-old (at the time of report) male patient of (b)(6) origin.Medical history was included heart disease.Concomitant medications were not provided.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix 50, 100 u/ml) from a cartridge via a reusable humapen ergo ii (blue plastic), 8 units twice a day, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2011.On an unknown date he after using insulin lispro mix50, there were brain infarction, hyperlipidemia and hypertension.The event of brain infarction was considered as serious by company due to its medically significance.On an unknown date, after using insulin lispro mix 50, the blood glucose was not well controlled.So, according to the doctor advice, the dose was changed from the previous dose (bid, 8 units per time) to 10 units per time, bid.On 25-mar-2020 the humapen ergo ii fell off by accident which caused the injection button could not be pushed down and the pen cap was lost (pc (b)(4), lot unknown).He was using the reusable humapen ergo ii since around 2011 to (b)(6) 2020 (improper use of the device).As of (b)(6) 2020 (at present), because the blood glucose was not well controlled, he fainted and was hospitalized.Information regarding corrective treatment and outcome of the events was not provided.Status of insulin lispro mix 50 was ongoing.The patient was the operator of the reusable humapen ergo ii device and his training status was not provided.The general reusable humapen ergo ii device model duration of use and suspect reusable device duration of use was around nine years as it started in 2011 (improper use of the device).The action taken with status of suspect reusable humapen ergo ii device was unknown.The status of suspect reusable humapen ergo ii device was unknown and the return status of suspect reusable humapen ergo ii device was not provided.The initial reporting consumer did not know if the events were related to insulin lispro mix 50 drug.The initial reporting consumer did not provide relatedness assessment between the events humapen ergo ii device.Updated 13-apr-2020: information was received from initial reporter via psp on 07-apr-2020.No new medically significant information received.Edit 23apr2020: updated medwatch and european and (b)(6) (eu/(b)(6)) 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(s) dated 24apr2020 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient reported that, on (b)(6) 2020, his humapen ergo ii device "fell off by accident which caused the injection button could not be pushed down." on (b)(6) 2020, the patient experienced abnormal blood glucose.The device was not returned to the manufacturer for investigation (batch 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.The patient reported that he had used the device since 2011 (9 years).The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.The core instructions for use also states if any of the parts of your humapen ergo ii appear broken or damaged, do not use, and to always carry a spare insulin pen in case your pen is lost or damaged.There is evidence of improper use.The patient used the device beyond the recommended use period.It is unknown if the misuse is relevant to the event of abnormal blood glucose.
 
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, concerned a 62-years-old (at the time of report) male patient of asian (han) origin.Medical history was included heart disease.Concomitant medications were not provided.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix 50, 100 u/ml) from a cartridge via a reusable humapen ergo ii (blue plastic), 8 units twice a day, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2011.On an unknown date he after using insulin lispro mix50, there were brain infarction, hyperlipidemia and hypertension.The event of brain infarction was considered as serious by company due to its medically significance.On an unknown date, after using insulin lispro mix 50, the blood glucose was not well controlled.So, according to the doctor advice, the dose was changed from the previous dose (bid, 8 units per time) to 10 units per time, bid.On (b)(6) 2020 the humapen ergo ii fell off by accident which caused the injection button could not be pushed down and the pen cap was lost ((b)(4), lot unknown).He was using the reusable humapen ergo ii since around 2011 to 25-mar-2020 (improper use of the device).As of (b)(6) 2020 (at present), because the blood glucose was not well controlled, he fainted and was hospitalized.Information regarding corrective treatment and outcome of the events was not provided.Status of insulin lispro mix 50 was ongoing.The patient was the operator of the reusable humapen ergo ii device and his training status was not provided.The general reusable humapen ergo ii device model duration of use and suspect reusable device duration of use was around nine years as it started in 2011 (improper use of the device).The suspect device was not returned to the manufacturer.The initial reporting consumer did not know if the events were related to insulin lispro mix 50 drug.The initial reporting consumer did not provide relatedness assessment between the events humapen ergo ii device.Updated 13-apr-2020: information was received from initial reporter via psp on 07-apr-2020.No new medically significant information received.Edit 23apr2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 24apr2020: additional information received on 24apr2020 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, and device return status to not returned to manufacturer for (b)(4) associated with unknown lot of a humapen ergo ii device.Corresponding fields and narrative updated accordingly.Update 27apr2020: additional information received on 27apr2020 from the global product complaint database.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
MDR Report Key9992606
MDR Text Key191479069
Report Number1819470-2020-00041
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 05/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMS9557
Was Device Available for Evaluation? No
Date Manufacturer Received04/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age62 YR
Patient Weight75
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