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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); Inaccurate Delivery (2339); Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Patient Problem Hypoglycemia (1912)
Event Date 10/31/2020
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred. A follow-up report will be submitted when the final evaluation is completed as necessary.
 
Event Description
Lilly case id: (b)(6). This report is associated with product complaint: (b)(4). This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerned a male patient of an unspecified age and origin. Medical history and concomitant medication was not provided. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30), from a cartridge, via humapen ergo ii, of unknown dose, subcutaneously, for diabetes mellitus, beginning on an unknown date in 2018. Humapen ergo ii was also started in 2018. On an unknown date in (b)(6) 2020, he experienced decreased blood glucose level (units, values and reference ranges were not provided) that led to hospitalization in the intensive care unit (icu) for five days. Approximately on (b)(6) 2020, the humapen ergo ii got impaired (pc no (b)(4)/lo no unknown) and it were stuck as it sometimes released insulin and sometimes did not as the injection button was stuck. He pressed on the injection button (took the dose in his arm) but as if he did not take the dose so it was suspected that he was taking an inadequate dose as after pressed, he has to check how many units taken and how many units were left. Outcome of events and corrective treatment was unknown. Status of human insulin isophane suspension 70%/human insulin 30% therapy was unknown. Follow up was not possible because permission to contact reporter and treating physician details were not provided. The patient was the operator of the humapen ergo ii and his training status was not provided. The general and suspect humapen ergo ii duration of use was about two years as it was started on an unknown date in 2018. The action taken with the humapen ergo ii and its return was unknown. The initial reporting consumer did not provide the relatedness of events with human insulin isophane suspension 70%/human insulin 30% therapy while related the events with humapen ergo ii. Edit 08dec2020: 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 Contact
chris davis
lilly corporate center
indianapolis, IN 46285
MDR Report Key10976816
MDR Text Key220636199
Report Number1819470-2020-00167
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 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
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 Received12/10/2020
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: 12/09/2020 Patient Sequence Number: 1
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