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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 No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Device not returned. Usage concerns resolved, and device was reported to be working properly. This is an initial report. A follow-up report will be submitted when the final evaluation is completed.
 
Event Description
(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 unknown origin. Medical history was not provided. Concomitant medication included metformin for an unknown indication. The patient received insulin lispro (rdna origin) (humalog 100u/ml) from cartridge via a reusable pen device (humapen ergo ii), at 8 units, thrice daily, for the treatment of diabetes mellitus, beginning sometime in (b)(6) 2016. Since an unknown date while on insulin lispro treatment, he had been hospitalized every year on unknown dates because of diabetes syndrome (diabetes mellitus inadequate control for which blood glucose values were not provided). On an unknown date, he experienced cerebral thrombosis for which he had been hospitalized since an unknown date. On (b)(6) 2020, his humapen ergo ii injection (humapen start date was unknown) screw could not move and injection button could not push down, and no medicine flowed out which was corrected by changing a new needle and then this issue was solved (pc number: (b)(4) and lot number: 1707d02). Information regarding additional corrective treatment and outcome for events was not provided. Insulin lispro treatment was continued. The operator of the humapen ergo ii device and his/her training status was not provided. The humapen ergo ii device general model duration was approximately nine months (started sometime in (b)(6) 2019) and the suspect humapen ergo ii device model duration of use was not provided. The humapen ergo ii device issue was resolved by changing a new needle and it was continued, so its return was not expected. The reporting consumer did not know if the events were related to insulin lispro treatment while did not provide the relatedness with its humapen ergo ii device. Edit 13may2020: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting. No new information added. Update 15-may-2020: additional information was received from the affiliate as a correction to the previous report received on 08-may-2020. The suspected humapen ergo ii start date was unknown and improper use was removed. Updated narrative with new information.
 
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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
Manufacturer (Section G)
TECH GROUP NORTH AMERICA INC. DBA WEST
640 south rockford drive
tempe, az
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, in 
4334585
MDR Report Key10061638
MDR Text Key200007400
Report Number1819470-2020-00049
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 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number1707D02
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2017
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: 05/15/2020 Patient Sequence Number: 1
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