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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 Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993); Device Fell (4014)
Patient Problem Hyperglycemia (1905)
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 solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter via psp, concerned a (b)(6) year-old (at the time of initial report) male patient of unknown origin. Medical history and concomitant medication was not provided. The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) injections (humalog mix 50) via cartridge via a reusable humapen ergo ii, of unknown dose and frequency, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 1992. On an unknown date in 2013 or 2014, he was hospitalized due to an unknown reason where he was presented humapen ergo ii. Due to high blood glucose (units, values and reference ranges were not provided), every month he was hospitalized. The outcome of event, corrective treatment details and status of insulin lispro protamine suspension 50%/ insulin lispro 50% therapy were not provided. Follow up was not possible because contact details of treating physician was not provided and the reporter denied to be contacted. The operator of the humapen ergo ii and his/her training status was not provided. The general humapen ergo ii model duration was approximately seven or eight years (stated in 2013 or 2014) and the suspect humapen ergo ii duration of use was not provided. The action taken with the suspect humapen ergo ii and its return status was not provided. The initial reporting consumer did not provide the relatedness of event with insulin lispro protamine suspension 50%/ insulin lispro 50% therapy and with humapen ergo ii. Update 31-aug-2021: this case was determined to be non-valid as no valid identifiable adverse event was reported (hospitalization). Update 07-sep-2021: this case was initially determined to be non-valid (no valid identifiable event). Additional information was received from the initial reporter via psp on 02-sep-2021, which contained a valid serious event of high blood glucose (as reason for hospitalization). Added: laboratory test of blood glucose. Updated: humapen ergo ii from concomitant to suspect device and product complaint (pc) was reprocessed. Narrative was updated with new information accordingly. Edit 08sep2021: updated medwatch and european 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)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
MDR Report Key12481564
MDR Text Key271771406
Report Number1819470-2021-00122
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 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2021
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 Received09/27/2021
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: 09/16/2021 Patient Sequence Number: 1
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