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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 Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Investigation in progress. A follow-up report will be submitted when the final evaluation is completed as necessary. This report is associated with 1819470-2020-00051 since there is more than one device implicated.
 
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 product complaint (pc), concerned a (b)(6) year-old (at the time of initial report) (b)(6) male patient. Medical history included coronary heart disease. Concomitant medications included acarbose and metformin both used for unknown indications. The patient received human insulin (rdna origin) injection (humulin series insulin, 100 u/ml), through cartridge via humapens (humapen unknown pen body type and humapen ergo ii), twice daily (bid, morning 18 night 19) subcutaneously for the treatment of diabetes mellitus, beginning around 2010. On an unknown date, after starting human insulin therapy, his blood glucose was not well controlled and there was hospitalization due to the event. Further information regarding hospitalization and discharge details were not provided. On an unknown date, he started using humapen unknown pen body type, whose dose knob was not accurate (b)(4), lot unknown) when it was adjusted and that humapen had been replaced. On an unknown date in (b)(6) 2020, he started using humapen ergo ii, whose slight blue soft touching rubber was peeling off (b)(4), lot 0902d05), and only a little of it was attached with the humapen ergo ii, due to which it could not be primed and dealt with according to procedure. Information regarding any corrective treatment and event outcome was not provided. On an unknown date in (b)(6)2020, human insulin treatment was discontinued due to unknown reason and it was unknown if it was restarted. The operator of the humapens and his or her training status was unknown. The general model humapen unknown pen body type duration of use and the suspect humapen unknown pen body type duration of use was not provided. The general model humapen ergo ii duration of use and the suspect humapen ergo ii duration of use was approximately three months as it was started in (b)(6) 2020. The humapen unknown pen body type was discontinued in (b)(6) 2020 and its return status was not provided, humapen ergo ii was replaced and returned to manufacturer. The reporting consumer did not know if the event was related to human insulin drug and did not provide relatedness of the events with humapens (humapen unknown pen body type and humapen ergo ii). Edit 14may2020: updated medwatch and (b)(6) (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 (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 Key10075814
MDR Text Key194647116
Report Number1819470-2020-00052
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 06/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number0902D05
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2009
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: 05/20/2020 Patient Sequence Number: 1
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