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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUMAPEN ERGO II; FOR TREATMENT PURPOSES
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HUMAPEN ERGO II; FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9557
Device Problems Failure to Deliver (2338); Difficult or Delayed Activation (2577); Mechanical Jam (2983)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Event Description
(b)(4).This spontaneous case, reported by a consumer to report adverse events, concerned a female patient of unknown age and origin.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog 50) from a cartridge via humapen ergo ii devices, three times a day, subcutaneously for the treatment of diabetes mellitus beginning on an unknown date.On unknown dates while on insulin lispro protamine suspension 50%/insulin lispro 50% therapy, she would be hospitalized every year due to poor glycemic control (no units, values and ranges were not provided).On an unknown date, the injection button of the humapen could not be pressed down ((b)(4); batch: unknown).On an unknown date in the beginning of (b)(6) 2021, the humapen was not so good to be used.The injection button could not be pressed down ((b)(4); batch: 1610d01).On an unknown date, she had belly pain after injection due to the fault of humapen ergo 2 injection pens.On an unknown date in (b)(6) 2021, she discontinued therapy due to the event and started on an unspecified oral drug for diabetes.On an unknown date while being on the oral medication, she had a relatively larger liver injury.Outcome for the events and information regarding corrective treatment were not reported.It was unknown if insulin lispro protamine suspension 50%/insulin lispro 50% was restarted.Status of unspecified oral drug was unknown.The operator of the humapen ergo ii devices and his/her training status were unknown.The humapen ergo ii device general device use was not provided.The device duration of use for the first suspect device was around four months and for the second suspect humapen device was around two years.Both the devices were returned to the hospital and replaced.The status at the manufacturer was unknown.The reporting consumer did not know the relatedness of the events with the insulin lispro protamine suspension 50%/insulin lispro 50% therapy.The initial reporting consumer related the event of belly pain with the humapen ergo ii devices whereas no relatedness was provided of the remaining events with the devices.The event of liver injury was associated with the unspecified oral drug.Edit 09-sep-2021: upon review updated the improper use and storage as yes for the devices.Updated the narrative with new information about the pc.Edit 09sep2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.
 
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 1819470-2021-00117 since there is more than one device implicated.
 
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 05oct2021 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2021-00117 since there is more than one device implicated.Evaluation summary.A female patient reported that the injection button of her humapen ergo ii device could not be pushed down.And insulin could not be injected.The patient experienced diabetes mellitus inadequate control.The investigation of the returned device (batch 1610d01, manufactured october 2016) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The patient's family reported that the needle was not changed for each injection.The core instructions for use state to use a new needle for each injection.There is evidence of improper use.The patient reused needles.This misuse may be relevant to the complaint and the event of diabetes mellitus inadequate control.
 
Event Description
Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer to report adverse events, concerned a female patient of unknown age and origin.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog 50) from a cartridge via humapen ergo ii devices, three times a day, subcutaneously for the treatment of diabetes mellitus beginning on an unknown date.On unknown dates while on insulin lispro protamine suspension 50%/insulin lispro 50% therapy, she would be hospitalized every year due to poor glycemic control (no units, values and ranges were not provided).On an unknown date, the injection button of the humapen could not be pressed down (pc number: (b)(4); batch: unknown).On an unknown date in the beginning of (b)(6) 2021, the humapen was not so good to be used.The injection button could not be pressed down (pc number: (b)(4); batch: 1610d01).On an unknown date, she had belly pain after injection due to the fault of humapen ergo 2 injection pens.On an unknown date in (b)(6) 2021, she discontinued therapy due to the event and started on an unspecified oral drug for diabetes.On an unknown date while being on the oral medication, she had a relatively larger liver injury.Outcome for the events and information regarding corrective treatment were not reported.It was unknown if insulin lispro protamine suspension 50%/insulin lispro 50% was restarted.Status of unspecified oral drug was unknown.The operator of the humapen ergo ii devices and his/her training status were unknown.The humapen ergo ii device general device use was not provided.The device duration of use for the humapen ergo ii device associated with (b)(4) was around two years and for the suspect humapen ergo ii device associated with (b)(4) was unknown.Both the devices were replaced.The humapen ergo ii (unknown lot) associated with product complaint (b)(4) was not returned to the manufacturer.The humapen ergo ii (lot 1610d01) associated with product complaint (b)(4) was returned to the manufacturer.On 02sep2021.The reporting consumer did not know the relatedness of the events with the insulin lispro protamine suspension 50%/insulin lispro 50% therapy.The initial reporting consumer related the event of belly pain with the humapen ergo ii devices whereas no relatedness was provided of the remaining events with the devices.The event of liver injury was associated with the unspecified oral drug.Edit 09-sep-2021: upon review updated the improper use and storage as yes for the devices.Updated the narrative with new information about the pc.Edit 09sep2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 05oct2021: additional information received on 29sep2021 from global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information and device ages.Updated "lot" number from 1610d01 to unknown for product complaint (b)(4) relating to the suspect humapen ergo ii which was not returned to the manufacturer.Added returned date, date of manufacturer and updated lot number from unknown to 1610d01, device available to returned to manufacturer for the humapen ergo ii device (lot 1610d01) associated with product complaint (b)(4) which was returned to the manufacturer.Corresponding fields and narrative updated accordingly.
 
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Brand Name
HUMAPEN ERGO II
Type of Device
FOR TREATMENT PURPOSES
MDR Report Key12530440
MDR Text Key281872179
Report Number1819470-2021-00118
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 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number1610D01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2021
Initial Date Manufacturer Received 08/26/2021
Initial Date FDA Received09/24/2021
Supplement Dates Manufacturer Received09/29/2021
Supplement Dates FDA Received10/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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