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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 Problems Failure to Deliver (2338); Difficult or Delayed Activation (2577); Mechanical Jam (2983)
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. This report is associated with 1819470-2021-00118 since there is more than one device implicated.
 
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 canadian (eu/ca) fields for expedited device reporting. No new information added.
 
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Brand NameHUMAPEN ERGO II
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
TECH GROUP NORTH AMERICA INC. DBA WEST
640 south rockford drive
tempe AZ 85281
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key12530526
MDR Text Key273310786
Report Number1819470-2021-00117
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
Date FDA Received09/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number1601D01
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/24/2021 Patient Sequence Number: 1
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