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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); Improper or Incorrect Procedure or Method (2017); 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. This report is associated with 1819470-2021-00066 since there is more than one device implicated.
 
Event Description
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This spontaneous case, reported by consumer who contacted the company to report adverse events and product complaint (pc), concerned a (b)(6) years old female patient of (b)(6) nationality. Medical history (complicating disease, allergic history, family medical history), previous drug adverse reaction and family drug adverse reaction were none. Concomitant medication included metformin and acarbose, for unknown indication. The patient received human insulin (rdna origin) injections (humulin r, 100u/ml) from cartridge via reusable device (humapen ergo ii), twice a day (12 units in the morning and 14 units in the evening), subcutaneously for the treatment of diabetes mellitus from around (b)(6) 2012. On an unknown date after starting human insulin therapy, she experienced high and unstable blood glucose during season change (no values and reference ranges were provided). In (b)(6) 2014, the whole pen body of the first humapen ergo ii was cracked and it was not so good to be used (pc (b)(4)/ lot number 1107d02). She was hospitalized in (b)(6) 2016, around (b)(6) 2017 and around (b)(6) 2020, respectively due to high and unstable blood glucose. In (b)(6) 2021, there was something at her home, which led to excessive internal heat, she got angry and her blood pressure was not good. The blood pressure was also high and did not sleep well. In around (b)(6) 2021, the black injection screw of the second humapen ergo ii was dropped and could not be used anymore (pc (b)(4)/ lot number 1210d03). Reportedly, she disassembled the both humapen ergo ii devices later, assembled it back and continued to use (this was considered as an improper use of the devices). On an unknown date, her blood pressure was 140-150 (up pressure (systolic pressure) or down pressure (diastolic pressure) were not obtained). On an unknown date, her blood pressure was 70-110, around 80-120, and at the same time, her pre-prandial blood glucose measured on (b)(6) 2021 was 9. 4 (no units were provided). Because of the perennial injection of human insulin, her belly had been punctured by needles. As of (b)(6) 2021, she changed to her human insulin dose to 16 units in the morning and 18 units in the evening by herself because the blood glucose was still high. She would be hospitalized if the blood glucose was still high. The patient was the operator of the humapen ergo ii devices and her training status was not provided. The humapen ergo ii devices model duration of use was not provided. The first suspect humapen ergo ii device duration of use was eight years as it was started since (b)(6) 2012. The second suspect humapen ergo ii device duration of use was five years as it was started since (b)(6) 2015. The use of both the suspect humapen ergo ii devices was ongoing and their return status was not provided. The reporting consumer did not know if the events were related to the human insulin therapy and did not provide a relatedness assessment for the events to the suspect humapen ergo ii devices. Edit 06-may-2021: upon review of the case, company analysis statement for the event of anger was added to the case and a technical issue due to which this event was missing from event assessment tab. No other changes were made to the case. Edit 07may2021: updated medwatch fields for expedited device reporting. No new information added. Edit 21may2021: updated medwatch 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 Key11864854
MDR Text Key266471608
Report Number1819470-2021-00065
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 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Device Lot Number1107D02
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2011
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: 05/21/2021 Patient Sequence Number: 1
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