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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 Mechanical Problem (1384); Inaccurate Delivery (2339)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Manufacturer Narrative
No further follow-up is planned. Evaluation summary a female patient reported that in her humapen ergo ii "got impaired when the dose was adjusted" and no insulin was being released. When she set higher doses, the device worked, but she was afraid it could get impaired again. The patient experienced increased blood glucose on (b)(6) 2020. 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. There is no evidence of improper use or storage.
 
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 an adverse event, concerned a female patient of unknown age and origin. Medical history and concomitant medications were not provided. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30), from a cartridge, via a reusable pen device (humapen ergo ii), at an unknown dose and frequency, subcutaneously, for diabetes mellitus, beginning approximately sometime in 2019. Approximately on (b)(6) 2021, while on human insulin 30/70 treatment, her humapen ergo ii got impaired when the dose was adjusted and pressed to release insulin, no insulin was being released (pc number: 5441360 and lot number: unknown) and she then tried to set the humapen ergo ii on high doses as 50iu and 60iu then tried using the humapen ergo ii again and it worked but she was afraid that the humapen ergo ii could get impaired again. Her blood glucose level sometimes reached 600 mg/dl as per the glucometer's reading (normal reference range not provided). The event was considered as serious due to medically significant reason. Information regarding additional corrective treatment and outcome for event was not provided. Human insulin 70/30 treatment was continued. The operator of the humapen ergo ii and his/her training status was not provided. The general humapen ergo ii model duration of use and the suspect humapen ergo ii model duration of use was approximately two years. The humapen ergo ii was continued and was not returned to the manufacturer. The reporting consumer did not provide any relatedness for the event with human insulin 70/30 treatment and its humapen ergo ii device. Edit 21jan2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting. No new information added. Update 27jan2021: additional information received on 25jan2021 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields/ european and (b)(6) (eu/(b)(6) ) device information and device return status to not returned to manufacturer for pc (b)(4) associated with unknown lot of humapen ergo ii device. Corresponding fields and narrative updated accordingly.
 
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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)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
MDR Report Key11265770
MDR Text Key233289256
Report Number1819470-2021-00013
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
Report Date 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2021
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2021
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: 02/02/2021 Patient Sequence Number: 1
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