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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hyperglycemia (1905)
Event Date 12/31/2008
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. This report is associated with 1819470-2020-00088 since there is more than one device implicated. This device was associated with increased blood glucose on (b)(6) 2008, (b)(6) 2012, (b)(6) 2016, and (b)(6) 2020 as well as decreased blood glucose on (b)(6) 2008, (b)(6) 2012, (b)(6) 2016, and (b)(6) 2020.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer, who contacted the company to report adverse events and product complaint (pc), concerned an (b)(6) year-old (b)(6) han female patient. Medical history included cataract, myopia and blurred eye. She was allergic to penicillin. Concomitant medications included acarbose, voglibose and atorvastatin, all for the treatment of unknown indications. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30), from cartridge via a reusable devices (humapen unknown and humapen ergo ii), twice daily, subcutaneously for diabetes mellitus, beginning in (b)(6) 2008. Dose was not provided. In (b)(6) 2008 and in (b)(6) 2012, while on human insulin isophane suspension 70%/human insulin 30% treatment, she was admitted in the hospital due to blood glucose could not be controlled down and it was sometimes high sometimes low (value, units and reference range were not provided). Reportedly, sometimes pre-prandial blood glucose was even higher than post-prandial. In 2013, she stopped taking human insulin isophane suspension 70%/human insulin 30% treatment due to an unknown reason and started taking insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog 50) from cartridge via a reusable devices (humapen unknown and humapen ergo ii), twice daily (16 units each morning and 12 units each evening), subcutaneously for diabetes mellitus. In (b)(6) 2016 to (b)(6) 2016 and in (b)(6) 2020, while on insulin lispro protamine suspension 50%/insulin lispro 50% treatment, she was admitted in the hospital due to blood glucose could not be controlled down and it was sometimes high sometimes low (value, units and reference range were not provided). Reportedly, sometimes pre-prandial blood glucose was even higher than post-prandial. On an unknown date, humapen unknown had issue and it was replaced afterwards (pc number: (b)(4), lot number: unknown). On an unknown date in (b)(6) 2020, injection button of humapen ergo ii required a lot of effort to press (pc number: (b)(4), lot number: 1201d01). Information regarding outcome and corrective treatment was not provided. Status of insulin lispro protamine suspension 50%/insulin lispro 50% treatment was continued. It was unknown if she would resume treatment with human insulin isophane suspension 70%/human insulin 30%. The patient was the operator of humapen unknown and humapen ergo ii and her training status was not provided. The general humapen unknown and humapen ergo ii duration of use and suspect humapen unknown and humapen ergo ii was not provided. The humapen unknown was stopped on an unknown date and humapen ergo ii was continued. Information regarding their return was not provided. The initial reporting consumer did not know if the events of high glucose (first and second episodes) and low glucose (first and second episodes) were related and did not associate remaining events to human insulin isophane suspension 70%/human insulin 30% treatment. The initial reporting consumer did not know if the events of high glucose (third and fourth episodes) and low glucose (third and fourth episodes) were related and did not associate remaining events to insulin lispro protamine suspension 50%/insulin lispro 50% treatment. The initial reporting consumer did not provide an opinion of relatedness between the events and humapen unknown and humapen ergo ii. Edit 22jul2020: updated medwatch 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, 46285
Manufacturer (Section G)
TECH GROUP NORTH AMERICA INC. DBA WEST
640 south rockford drive
tempe,
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, in 
MDR Report Key10323859
MDR Text Key208231106
Report Number1819470-2020-00087
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 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberMS9557
Device Lot Number1201D01
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2020
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: 07/24/2020 Patient Sequence Number: 1
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