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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 Material Too Rigid or Stiff (1544); Use of Device Problem (1670); Improper Flow or Infusion (2954); Mechanical Jam (2983); Patient Device Interaction Problem (4001)
Patient Problems Hyperglycemia (1905); Localized Skin Lesion (4542)
Event Date 01/31/2020
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
(b)(4). This report is associated with product complaint: (b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) year-old (at the time of initial report) female patient with unknown an origin. Medical history included diabetes since she was (b)(6) years-old. Concomitant medications were not provided. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30), from cartridge via a reusable device humapen ergo ii, 40 international units in the morning and 28 international units in the evening; twice daily, subcutaneously, for the treatment of type 1 diabetes mellitus, beginning on an unknown date (reported as more than 30 years). She was using humapen ergo ii application pen since (b)(6) 2019. Since (b)(6) 2020, some application pen had problems in short time, but some were functioning for a long time which lasted the application pen used for a long time. The ball of the application pen was not pressed due to its hardness and it was not moving. The ball was not like that when the application pen was new. She felt tired when she was trying to receive insulin with pushing the ball. The piston was hardened and she had trouble with needle tip since it caused pain due to excessive force. The insulin did not receive quickly and she pushed the application pen and it caused pain (batch number: 1502d01 and product complaint number: (b)(4)). Since an unknown date in 2020, while on human insulin isophane suspension 70%/human insulin 30%, she itched which converted into wound due to diabetes/high blood sugar (value, unit and reference range not provided) due to which she was hospitalized on (b)(6) 2020 and discharged after one week. Information regarding further hospitalization details and corrective treatment was not provided. Outcome of the events diabetic wound and high blood sugar was resolving while that of remaining events was not provided. The status of human insulin isophane suspension 70%/human insulin 30% therapy was not provided. Follow up was not possible since the reporter did not give consent herself and her doctors for follow up procedures. The patient was the operator of humapen ergo ii and her training status was not provided. The general humapen ergo ii duration and suspect humapen ergo ii duration was not provided however it was started in (b)(6) 2019. Action taken with humapen ergo ii and its return status was were not provided. The initial reporting consumer did not provide the relatedness assessment of the events with human insulin isophane suspension 70%/human insulin 30% therapy and humapen ergo ii. Update 05-apr-2021: information was received on 31-mar-2021 from the responsible contact person (rcp) provided the product complaint (pc) reference number (b)(4)). No medically significant information was added. No further changes were done to the case. Edit 20apr2021: 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 Key11713618
MDR Text Key262520064
Report Number1819470-2021-00051
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 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Device Lot Number1502D01
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2015
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: 04/23/2021 Patient Sequence Number: 1
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