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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 Mechanical Problem (1384)
Patient Problems Bone Fracture(s) (1870); Hyperglycemia (1905); Impaired Healing (2378)
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 spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a male patient of an unknown age and origin. Medical history was not provided. Concomitant medications included insulin glargine for unknown indication. The patient received insulin lispro (rdna origin) injections (humalog, 100 u/ml) from a cartridge via a reusable device humapen ergo ii, 25, 26, 28 units twice a day while eating the meal, subcutaneously for the treatment of diabetes mellitus beginning approximately in 2010. He started humapen ergo ii approximately in 2010. On an unknown date while insulin lispro treatment taking he had diabetes mellitus consequences and had slow wound healing and bone fracture (cataclasis) for which he was hospitalized for two months. Also, sometimes the blood glucose was high (values, units and reference range not provided), therefore dose of insulin lispro was increased 31 or 32 once in the morning, at noon and night respectively three times day. Sometime in 2019, the humapen ergo ii pen does not had clicking sound when it was pressed one time until the end which was not controlled and sometimes only clicked one or two sound was heard when injection button was pressed down until the end due to humapen ergo ii issue (pc#: (b)(4); lot#: 0910d02). He used humapen ergo ii for ten year which was considered as improper use. Information regarding further hospitalization details, corrective treatment and outcome of the events was not provided. Insulin lispro treatment was continued. No additional follow-up would be attempted as the reporter refused to be followed up via phone and no physician contact information was provided. The operator of the humapen ergo ii was unknown and his/her training status was not provided. The general model humapen ergo ii duration of use was not provided and the suspect humapen ergo ii duration of use was approximately ten years as it was started approximately in 2010. The patient continued to use the humapen ergo ii and its return status was not reported. The reporting consumer did not provide any opinion on relatedness assessment between the events and insulin lispro drug or with humapen ergo ii device. Update 25-aug-2020: initial information received on (b)(6) 2020 and follow up information received on 21-aug-2020 was processed together. Edit 28aug2020: updated medwatch and (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 Key10476461
MDR Text Key210162842
Report Number1819470-2020-00113
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 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number0910D02
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2009
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: 09/01/2020 Patient Sequence Number: 1
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