• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9557
Device Problems Fluid Leak (1250); Physical Resistance/Sticking (4012)
Patient Problems Fatigue (1849); Headache (1880); Hyperglycemia (1905); Blurred Vision (2137)
Event Date 06/17/2020
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
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This solicited case, reported by a consumer via a patient support program (psp), with additional information from initial reporting consumer via a psp, concerned a (b)(6) year-old female patient of unspecified ethnicity. Medical history included diabetes since before 1990. Concomitant medication was not provided. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30) via reusable device (humapen ergo ii), subcutaneously, for treatment of diabetes, beginning on an unknown date since before 1990. Dosage regimen was not provided. On approximately (b)(6) 2020 or (b)(6) 2020, after starting human insulin isophane suspension 70%/human insulin 30% therapy, the screw of humapen ergo ii got stuck and the screw did not push the plunger to release the human insulin isophane suspension 70%/human insulin 30%. Reportedly, the needles were changed every other day, as she was dispensed only 15 needles from hospital (improper use of device). There was human insulin isophane suspension 70%/human insulin 30% leakage (pc 5201679/ lot number unknown) which was the cause that she suffered from high blood glucose (no values and reference ranges were provided). Since an unknown date, she suffered from high blood pressure (no values and reference ranges were provided) which was correlative with high blood glucose and it started after taking the human insulin isophane suspension 70%/human insulin 30%, she changed many drugs for high blood pressure. She was taking her doses using insulin syringe since pen got impaired. With insulin syringe, it was difficult for her to take her doses as she could not adjust the dose (suspicious of inaccurate dose) and that led to the following high blood glucose. On an unknown date she was very tired and due to high blood glucose, which reached 228 mg/dl last time they measured, she suffered from headache and blurry vision. As long as blood glucose increased, the blood pressure increased reaching last time measured 140/90 mmhg. She went to the hospital many times due to the events of high blood glucose and high blood pressure, but was not hospitalized due to coronavirus situation as hospital refused to hospitalize her. The events were considered serious due to medical significance. The outcome of event tiredness was unknown while she did not recover from the remaining events. Information regarding further corrective treatment was not provided. Human insulin isophane suspension 70%/human insulin 30% was ongoing. The operator of the humapen ergo ii and his/her training status were not provided. The humapen ergo ii model duration of use and the suspect humapen ergo ii duration of use were not provided. The use of the suspect humapen ergo ii was discontinued and its return was expected. The reporting consumer did not provide a relatedness assessment for the events to human insulin isophane suspension 70%/human insulin 30% therapy. The reporting consumer related the event of incorrect dose administered with insulin syringe and did not provide the relatedness of event tiredness with humapen ergo ii while related the remaining events with the humapen ergo ii issue. Update 09-jul-2020: additional information was received from initial reporting consumer via a psp on (b)(6) 2020. Added: four non-serious events of incorrect dose administered, fatigue, headache and vision blurred, two laboratory test of blood glucose and blood pressure. Updated: as reported verbatim of events blood glucose increased and blood pressure increased. Causality statement and narrative was updated with new information accordingly. Edit 10jul2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting. No new information added.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHUMAPEN ERGO II
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis, in
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, 
4334585
MDR Report Key10273163
MDR Text Key205759903
Report Number1819470-2020-00082
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 07/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2020
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: 07/14/2020 Patient Sequence Number: 1
-
-