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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 Material Too Rigid or Stiff (1544); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339); Physical Resistance/Sticking (4012)
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)-year-old female patient of an unknown origin. Medical history and concomitant medications were not provided. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100 u/ml) from a cartridge via a reusable device humapen ergo ii, at an unknown dose and frequency subcutaneously for the treatment of diabetes beginning on an unknown date before 2006. She started humapen ergo ii approximately in 2006 or 2011 (which was considered as improper use). On an unspecified date, (reported as few months from initial receipt date (b)(6) 2021) while taking human insulin isophane suspension 70%/human insulin 30% treatment, her humapen ergo ii was impaired and became heavy while pressing on the injection button to release the dose. Because of this, sometimes she was not sure whether she took accurate dose or not; which made her high blood glucose that reached 500s mg/dl (reference range not provided) (pc unknown, lot 1110d03). She was admitted to the hospital to normalize her blood glucose level before cataract surgery. In addition, she had weak eyesight, and cataract for which she underwent cataract surgery sometime in 2011 or 2013. Information regarding further hospitalization details and corrective treatment for remaining events was not provided. Outcome of the events was not resolved. Human insulin isophane suspension 70%/human insulin 30% treatment was continued. The operator of the humapen ergo ii device was unknown and his/her training status was not provided. The general model humapen ergo ii device duration of use was not provided and the suspect humapen ergo ii duration of use was approximately fifteen years as it was started approximately in 2006 or 2011. The action taken with humapen ergo ii was not provided and its return status was expected. The reporting consumer did not relate the events high blood glucose and incorrect dose administered and did not provide any opinion on relatedness assessment between the remaining event and human insulin isophane suspension 70%/human insulin 30% drug. The reporting consumer related the events high blood glucose and incorrect dose administered and did not provide any opinion on relatedness assessment for the remaining event with humapen ergo ii device. Edit 04mar2021: updated medwatch and european and (b)(6) (eu/(b)(6)) 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 Key11562868
MDR Text Key258893365
Report Number1819470-2021-00040
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 04/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number1110D03
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2011
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: 03/24/2021 Patient Sequence Number: 1
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