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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 Problems Neuropathy (1983); Ambulation Difficulties (2544)
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 compliant: (b)(4). This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint, concerned a (b)(6) (at the time of initial report) female patient of asian (b)(6) origin. Medical history was not provided. Concomitant medications included insulin glargine for the treatment of diabetes mellitus. The patient received human insulin (rdna origin) injections (humulin unspecified type, 100u/ml) from a cartridge, via a reusable humapen ergo ii (blue with a little grey), with unknown dose and frequency, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date. On an unknown date, while on human insulin she changed to insulin as part according to the doctor instructions (reason for the change and the change time were not provided). During the use of insulin aspart, because the blood sugar was high (when fasting, it was 20) and diabetes kidney/ diabetic kidney, she was hospitalized on (b)(6) 2019, and discharged on (b)(6) 2019. During the hospitalization, she changed from insulin aspart to human insulin (rdna origin) (humulin r) 14 units three times a day (morning, noon and night) according to the doctor instructions (the reason for the change and the change time were not provided). While on human insulin (humulin r), the complications that neuropathy, leg could not walk, maculopathy of fundus and edema occurred. The events of could not walk and maculopathy of fundus were considered as serious by company due to their medically significance. Since an unknown date, there were situations in the humapen ergo ii (blue color) injection pen that the pen cap was lost, the injection pen was damaged and it was laborious to use. She changed the needle once a day (improper use of the device). It was also noted the pen cap of the injection pen was cracked (pc (b)(4), lot number 1102d02). This pen had already been replaced. On (b)(6) 2019, two days ago she got a new replaced pen, this pen was just got by replacement. She had not injected insulin human r for two days due to the newly replaced pen (2nd pen) issue; further described, it could not push insulin out and it could not be pushed down (pc (b)(4), lot number unknown). She changed the needle once a day (improper use of device). She was notified to change a new needle and it was phone solved. Information regarding further corrective treatment was not provided. Outcome of the events was not recovered. It was unknown if human insulin (unspecified type) and insulin aspart would be restarted. Status of human insulin (regular) was ongoing. The patient was the operator of the reusable humapen ergo ii devices and her training status was not provided. The general reusable humapen ergo ii device model duration of use was unknown. The suspect reusable device duration of use for humapen ergo ii associated with product complaint (b)(4) was unknown while the suspect reusable device duration of use for humapen ergo ii associated with product complaint (b)(4) was one day. The status of the suspect reusable humapen ergo ii device associated with product complaint (b)(4) was unknown and the return of status of suspect reusable humapen ergo ii device was not provided. The status of suspect reusable humapen ergo ii device associated with product complaint (b)(4) was ongoing and the return of status was not expected. The reporting consumer did not know if the events were related to human insulin (unspecified type), insulin aspart and human insulin regular. The reporting consumer did not provide relatedness assessment between the events and reusable humapen ergo ii devices. This case was cross-referenced with case (b)(4) (same patient). Update 14-nov-2019: information received on 08-nov-2019 and 11-nov-2019 was processed together. Update 15nov2019: additional information received on 14-nov-2019 from global product complaint database reiterated the lot number 1102d02 for product complaint (b)(4) relating to the humapen ergo ii device, which was already present and correct in the case. Corresponding fields and narrative updated accordingly. Update 21-nov-2019: information was received on 19-nov-2019. Pc number received which was already processed. No new medically significant information was added to the case. Edit 02dec2019: updated medwatch and european and canadian (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)
PHILLIPS-MEDISIZE CORPORATION
415 red cedar street
medical device manufacturing
menomonie WI 54751
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key9410293
MDR Text Key187234285
Report Number1819470-2019-00212
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 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Device Lot Number1102D02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2011
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: 12/04/2019 Patient Sequence Number: 1
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