• 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 Problem Activation, Positioning or SeparationProblem (2906)
Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Visual Impairment (2138); Dizziness (2194); Sleep Dysfunction (2517); Missed Dose (2561)
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 spontaneous case, reported by consumer who contacted the company to report adverse events and product complaints (pc), concerned a (b)(6) years old female patient of (b)(6) nationality. Medical history (comorbidity, allergy history, family history) and previous medical history included eyes not good, hypertension, kidney disease and cerebral blood point (as reported). Family history included hypertension. Allergy history included sulfonamide allergy. Previous drug adverse reaction and family drug reaction were unknown. Concomitant medication included metformin for diabetes mellitus. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from cartridge via reusable device (humapen ergo ii), twice daily (36 units in morning and 28 units at night), subcutaneously, for the treatment of diabetes mellitus, from second half of 1999. On an unknown date, after starting human insulin isophane suspension 70%/human insulin 30% therapy, she had occurred complication of eyes not good (improper use of the device), hypertension (high blood pressure, no values and reference ranges were provided) and kidney disease (nephropathy). Reportedly, on an unknown date, the injection button of the first humapen ergo ii could not be pushed down and the human insulin isophane suspension 70%/human insulin 30% could not flow out (b)(4), lot number 1110d02) and she would change the injection pen needle every three days (improper use of the device). She also experienced dizziness, inability to see, could not sleep and high blood glucose (fasting blood glucose at 15-16, no units and reference ranges were provided). In (b)(6) 2016, she was hospitalized due to dizziness, inability to see, could not sleep and high fasting blood glucose. During the period of hospitalization, she experienced penicillin, potassium allergy and her arm could not move (the event of arm could not move was considered serious due to medical significance). Her dose was changed from 36 in the morning and 28 in the evening to 40 in the morning and 32 in the evening according by advice of the doctor during the period of hospitalization. She was discharged after 21 days. The situation of dizziness, inability to see, could not sleep and high blood glucose (fasting blood glucose at 15-16) was recovering. The situations of penicillin, potassium allergy and arm could not move had not become recovering until half a year later in (b)(6) 2017. In (b)(6) 2019, she started a new humapen ergo ii. The injection button of this humapen ergo ii could not be pushed down and the human insulin isophane suspension 70%/human insulin 30% could not flow out (the injection button could not be pressed if the humapen ergo ii had human insulin isophane suspension 70%/human insulin 30% installed and if not installed, it can be pressed). She had changed the needle and debugged by herself, but the medicine still could not be injected (b)(4), lot number 1809d01). Information regarding corrective treatment and outcome for the event of missed dose was not provided. She was recovering from the remaining events. Status of human insulin isophane suspension 70%/human insulin 30% therapy was ongoing. The patient was the operator of the humapen ergo ii and her training status was not provided. The humapen ergo ii model duration of use was not provided. The first suspect humapen model duration of use was not provided. The second suspect humapen ergo ii duration of use was eight months as it was started in (b)(6) 2019. The use of the first suspect humapen ergo ii was discontinued and the use of the second suspect humapen ergo ii was ongoing. The return status for both the suspect humapen ergo ii was not provided. 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 missed dose with the second suspect humapen ergo ii device issue and did not provide a relatedness assessment for the remaining events to both humapen ergo ii devices. Edit 13may2020: updated medwatch and (b)(6) fields for expedited device reporting. No new information added. Update 13-may-2020: upon internal review the medical history of cerebral blood point was added into the case. No medically significant information was provided. Narrative was updated accordingly. Update 18-may-2020: both the information was received from the initial reporting consumer on (b)(6) 2020 reiterating the previously reported information. No further changes were made to the case.
 
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 (Section G)
TECH GROUP NORTH AMERICA INC. DBA WEST
640 south rockford drive
tempe, az
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, in 
4334585
MDR Report Key10070572
MDR Text Key195100050
Report Number1819470-2020-00048
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 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberMS9557
Device Lot Number1110D02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2011
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: 05/19/2020 Patient Sequence Number: 1
-
-