• 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 SAVVIO 3ML (GRAPHITE) 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 SAVVIO 3ML (GRAPHITE) FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9698
Device Problem Failure to Deliver (2338)
Patient Problems Hyperglycemia (1905); Confusion/ Disorientation (2553)
Event Date 02/06/2020
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), concerned a (b)(6)-year-old female patient of an unknown origin. Medical history included hypertension. Concomitant medications included unspecified medications for hypertension. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100 u/ml) from an unknown formulation via a reusable device humapen savvio (graphite), 50 iu in the morning and 20 iu at night two times a day subcutaneously for the treatment of diabetes mellitus beginning approximately in 2015. He started humapen savvio (graphite) approximately in 2018. On (b)(6) 2020 while on human insulin isophane suspension 70%/human insulin 30% treatment, the screw of the injection pen was stuck and could not release insulin dose (pc#: unknown; lot#: 1310v01) and due to the humapen savvio issue she missed to inject the dose of human insulin isophane suspension 70%/human insulin 30% for five days. On (b)(6) 2020, she had hyperglycemia associated with hallucination and confusion therefore ambulance was called and transferred to the hospital where she stayed for four hours until her blood glucose level was adjusted, however treating physician believed she could have been comatose unless she was transferred to the hospital. Further her blood sugar was elevated due to missed dose. The events hyperglycemia, hallucination and confusion were considered as serious due to medical significance reasons. Since (b)(6) 2020 she started taking human insulin isophane suspension 70%/human insulin 30% doses using the insulin syringe. On (b)(6) 2020 her blood glucose level was return to normal. Information regarding corrective treatment was not provided. Outcome of the events was resolved. Human insulin isophane suspension 70%/human insulin 30% treatment was continued. The operator of the humapen savvio (graphite) was unknown and his/her training status was not provided. The general model humapen savvio (graphite) duration of use was not provided and the suspect humapen savvio (graphite) duration of use was approximately two years as it was started approximately in 2018. The humapen savvio (graphite) was discontinued in (b)(6) 2020 and its return status was expected. The reporting consumer did not relate the events to human insulin isophane suspension 70%/human insulin 30% drug. The reporting consumer related the events to the humapen savvio (graphite) device issue. Edit 18feb2020: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting. No new information added.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHUMAPEN SAVVIO 3ML (GRAPHITE)
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 Key9728965
MDR Text Key185911621
Report Number1819470-2020-00019
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K160668
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9698
Device Lot Number1310V01
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2013
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: 02/19/2020 Patient Sequence Number: 1
-
-