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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 Loose or Intermittent Connection (1371); Use of Device Problem (1670); Connection Problem (2900); Material Integrity Problem (2978); Priming Problem (4040)
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.
 
Event Description
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) years-old asian male patient. Medical history included high blood pressure, high blood lipid, high cholesterol and high triglyceride. Concomitant medication included metformin for the treatment of diabetes mellitus. The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog 25) from cartridge via humapen ergo ii device, 28 units twice daily subcutaneously, for the treatment of type ii diabetes, beginning somewhere in 2019. On an unknown date in (b)(6) 2021, while on insulin lispro protamine suspension 75%/insulin lispro 25% therapy, he got hospitalized due to poor blood glucose control. He also had some issue with his humapen ergo ii device, the screw head of cartridge holder of pen was slippery and was not screwing tightly. He was not able to prime due to this issue (pc number: 5540160; lot number: unknown). Information regarding the corrective treatment and outcome of the event was not provided. Insulin lispro protamine suspension 75%/insulin lispro 25% therapy was continued. The operator of the humapen ergo ii device was patient himself and his training status was not provided. The general humapen ergo ii device model duration of use was not provided but it was started somewhere in 2019. The duration of use of suspect humapen ergo ii device was unknown. The action taken with suspect humapen ergo ii device was not provided and its return was not reported. The reporting consumer did not provide the relatedness assessment between the event or the suspect humapen ergo ii device. Edit 14apr2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting. No new information added. Edit 15-apr-2021: updated few eu/ca fields. No further changes were made to the case.
 
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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 Key11695350
MDR Text Key246797599
Report Number1819470-2021-00057
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 company representative,consum
Type of Report Initial,Followup
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2021
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: 04/20/2021 Patient Sequence Number: 1
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