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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 Crack (1135); Fracture (1260)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Manufacturer Narrative
Since the device is not being returned, evaluation for a malfunction is not possible. A follow-up report will be submitted when the final evaluation is completed as necessary.
 
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 and product complaint (pc), concerned a male 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) injection (humalog 50, 100u/ml) from cartridge via humapen ergo ii, of unknown dose and frequency via unknown route, for type ii diabetes mellitus, beginning on an unknown date in 2013 or 2014 (conflicting information). Humapen ergo ii was started in 2013 or 2014 (conflicting information) (improper use). On an unknown date, while on insulin lispro protamine suspension 50%/insulin lispro 50% therapy, due to pre-existing type ii diabetes mellitus, he was hospitalized (further hospitalization details were not provided). On an unknown date, the cartridge holder of the humapen ergo ii was cracked and it had already been discarded (pc no (b)(4)/lot no unknown). The outcome of event and corrective treatment details was unknown. Status of insulin lispro protamine suspension 50%/insulin lispro 50% therapy was continued. Follow up was not possible because treating physician contact details were not provided and reporter was not willing to be contacted. The operator of the humapen ergo ii was unknown and his/her training status was not provided. The general humapen ergo ii and the suspect humapen ergo ii duration of use was approximately six or seven years as it was started in 2014 or 2014. The humapen ergo ii was discarded and its return was not possible. The initial reporting consumer considered the relatedness of event with insulin lispro protamine suspension 50%/insulin lispro 50% therapy, as unknown while did not provide its relatedness with humapen ergo ii. Edit 11nov2020: updated medwatch and european and canadian (eu/ca) fields and added contact log according 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 Key10824053
MDR Text Key215885695
Report Number1819470-2020-00159
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 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2020
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2020
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: 11/11/2020 Patient Sequence Number: 1
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