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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 Improper or Incorrect Procedure or Method (2017); Failure to Deliver (2338)
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.
 
Event Description
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This solicited case, reported by two consumer reporters via a patient support program (psp), concerned a (b)(6) years-old female patient of unknown origin. Medical history included and concomitant medications were not provided. The patient received human insulin (rdna origin) regular (humulin r) from a cartridge, via a reusable pen device (humapen ergo ii), at 20 international units (iu), three times daily, subcutaneously, for the treatment of diabetes, beginning sometime in 2012. She started using unknown his current humapen ergo ii approximately sometime in (b)(6) 2019 (reported as one year and two to four months ago). She had been using unknown devices in past. Sometime in (b)(6) 2020 (from four weeks), while on human insulin treatment, her humapen ergo ii got impaired (pc number: (b)(4) and lot number: 1710d04) as when she adjusted the dose on 30 iu and pushed the injection button, it did not release any insulin, after which her physician gave her another grey (as reported) insulin pen to be taken once at night but she did not know the name of the insulin. On an unknown date, she started to suffer from persistent high glucose blood level (values, units and normal reference range not provided) and from sudden persistent leg swelling that was not decreased; due to both which she underwent an amputation surgery on her toe from eight months, sometime in (b)(6) 2020 for which she was hospitalized for three days. She exchanged the needle with every cartridge (every week), was considered to be improper use. Information regarding additional corrective treatment, hospitalization dates and outcome for events was not provided. Human insulin treatment was continued. The patient was the operator of the humapen ergo ii and her training status was not provided. The general humapen ergo ii model duration of use was approximately sixteen months and the suspect humapen ergo ii model duration of use was not provided. The action taken with the suspect humapen ergo ii and its return status was not provided. No troubleshooting was done. The reporting consumers did not provide any relatedness for the event with human insulin treatment and humapen ergo ii. Update 12-jan-2021: this case was determined to be non-valid as there was no identifiable valid event however patient had toe amputation (reason unspecified). Update 16-feb-2021: additional information received from the initial reporter in response to the follow-up attempt on 14-feb-2021 via psp. This case became valid per addition of serious events of high blood glucose and persistent leg swelling with hospitalization criteria. Added; laboratory tests for blood glucose. Removed event of toe amputation. Updated; humapen ergo ii device type to suspect, causality statement and narrative with new information. Edit 18feb2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting. No new information added. Edit 18-feb-2021: upon review of information received on 14-feb-2021, outcome for events was updated to unknown (previously: recovered) and improper use was added to case device field and in narrative. No other changes were made.
 
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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 Key11358996
MDR Text Key242037112
Report Number1819470-2021-00032
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 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Device Lot Number1710D04
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2017
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: 02/22/2021 Patient Sequence Number: 1
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