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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 Failure to Zero (1683); Appropriate Term/Code Not Available (3191)
Patient Problem Hypoglycemia (1912)
Event Date 12/28/2019
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 a product complaint (pc) and adverse event, concerned a (b)(6) year-old male patient of han nationality. Medical history and concomitant medications were not provided. The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog 25, 100 u/ml) from a cartridge via a reusable device humapen ergo ii, 14 or 16 units in the morning and 12 units at night subcutaneously for the treatment of diabetes mellitus beginning approximately in 2012. He started humapen ergo ii approximately in 2012. On an unknown date while taking insulin lispro protamine suspension 75%/insulin lispro 25% treatment he had unstable blood sugar because he ate sometime more, ate sometime less and sometime could not ate at all and she like to do farm work and his diet control was not particularly good however he had sudden hypoglycemia for which he was hospitalized on (b)(6) 2019. Further device dose window could not return to zero and could not stay in the body for five seconds after the injection of insulin (pc#: (b)(4); lot#: unknown). Information regarding further hospitalization details, corrective treatment and outcome of the event was not provided. Insulin lispro protamine suspension 75%/insulin lispro 25% treatment was continued. The operator of the humapen ergo ii was unknown and his/her training status was not provided. The general model humapen ergo ii duration of use was not provided and the suspect humapen ergo ii duration of use was approximately seven years as it was started approximately in 2012. The patient continued to use the humapen ergo ii and its return status was not reported. The reporting consumer did not know whether the event was related to insulin lispro protamine suspension 75%/insulin lispro 25% drug or not and did not provide relatedness assessment between the event and humapen ergo ii device. Update 03-feb-2020: information was received on 23-jan-2020 contained product complaint (pc) number. Pc number would be processed accordingly and no new information was added to the case. Edit 10feb2020: updated medwatch and european and (b)(6) (eu/(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
Manufacturer (Section G)
PHILLIPS-MEDISIZE CORPORATION
415 red cedar street
medical device manufacturing
menomonie, wi
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, in 
4334585
MDR Report Key9707584
MDR Text Key189157455
Report Number1819470-2020-00017
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 03/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2020
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 Received02/19/2020
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: 02/13/2020 Patient Sequence Number: 1
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