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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 Crack (1135); Fracture (1260)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred. A follow-up report will be submitted when the final evaluation is completed as necessary.
 
Event Description
Lilly case id: (b)(6). This report is associated with product complaint: (b)(4). This spontaneous case, reported by a consumer who contacted the company to report an adverse event, and product complaint (pc), concerned a (b)(6)-year-old (b)(6) male patient. Medical history was none. Concomitant medication included bailing capsule (as reported) for unknown indication. The patient received insulin lispro protamine suspension 75%/insulin lispro 25% treatment (rdna origin) injections (humalog mix25), from cartridge via a reusable device humapen ergo ii (blue), thrice daily (morning 10, noon 2, night 12), subcutaneously for the treatment of diabetes mellitus, beginning in 2010. In 2018, while taking insulin lispro protamine suspension 75%/insulin lispro 25% treatment, the screw thread of the clear cartridge holder near the rear end of a humapen ergo ii (blue) was cracked (lot number: 0912d02, pc number: (b)(4)). Reportedly, the issue could not be solved by phone, therefore the pen was processed based on procedure. On (b)(6) 2020, he was hospitalized due to regulating blood glucose (value, units and reference range were not provided). Further information regarding corrective treatment and outcome of the event was not provided. Status of insulin lispro protamine suspension 75%/insulin lispro 25% treatment was continued. The operator of humapen ergo ii (blue) and his/her training status was not provided. The general humapen ergo ii (blue) model duration was not provided but the suspect humapen ergo ii (blue) was started in 2010; approximately 10 years. The status of humapen ergo ii (blue) was unknown and its return status was not provided. The initial reporting consumer did not know if the event was related to insulin lispro protamine suspension 75%/insulin lispro 25% treatment and did not provide relatedness of event with humapen ergo ii (blue). Update 04-dec-2020: information received on 02-dec-2020 and 03-dec-2020 were processed at same time. Edit 08dec2020: 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)
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 Key10984826
MDR Text Key222625377
Report Number1819470-2020-00171
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 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number0912D02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/31/2009
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: 12/10/2020 Patient Sequence Number: 1
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