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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 Difficult or Delayed Activation (2577)
Patient Problem Confusion/ Disorientation (2553)
Event Date 06/30/2020
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, concerned a female patient of unknown age and origin. Medical history was not provided. Concomitant medication included voglibose for unknown indication. The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) (humalog mix50) cartridge via a insulin injection pen(humapen, unknown from 2008) 16 units twice a day, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date. On an unknown dates, sometimes her pre-prandial blood glucose was higher than postprandial (no unit, value or reference range was provided). Her first insulin pen had some issue around 2013 and it was replaced (lot number: unknown, pc number: (b)(4)). From an unknown date in 2013, she started to use humapen ergo ii (blue plastic). On an unknown date in (b)(6) 2020, the injection button of humapen ergo ii was difficult to press. On an unknown date in (b)(6) 2020 her blood glucose control was poor (lot number: 1201d01, pc number: (b)(4)) and she was hospitalized for it. In addition, she had the condition of brain muddled (confusion). Information regarding corrective treatment and outcome of events was unknown. Insulin lispro protamine suspension 50%/ insulin lispro 50% treatment was continued. No follow-up was possible as reporter did not provide consent and no physician contact details were provided. The patient was the operator of the reusable devices and her training status was not provided. The general device model duration of use for the humapen, unknown device was unknown but it started on an unknown date in 2008. The suspect device duration of use for the humapen, unknown device was not provided. The suspect humapen, unknown device associated with pc (b)(4) was replaced in 2013 and its return was not expected. The general device model duration of use for the humapen ergo ii device was unknown. The suspect device duration of use for the humapen ergo ii device was approximately seven year as it started around 2013. The use of humapen ergo ii device associated with pc (b)(4) (lot 1201d01) was continued and its return was expected. The reporting consumer did not know if the events were related to insulin lispro protamine suspension 50%/ insulin lispro 50% whereas did not provide an opinion of relatedness between the events and unknown humapen and humapen ergo ii. Update 20-jul-2020: initial and follow-up information received on 16-jul-2020 was processed together. Edit 22jul2020: updated medwatch fields for expedited device reporting. No new information added. Edit 23-jul-2020: updated report type from solicited to spontaneous in narrative.
 
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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 Key10322355
MDR Text Key208325201
Report Number1819470-2020-00092
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 07/30/2020
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
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Device Lot Number1201D01
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2012
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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