• 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 (RED) 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 (RED) FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9694
Device Problems Mechanical Problem (1384); Failure to Deliver (2338); Mechanics Altered (2984); Output Problem (3005)
Patient Problem Hyperglycemia (1905)
Event Date 05/11/2021
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 a nurse, concerns a patient of unknown age, gender and ethnicity. Information regarding medical history and concomitant medication was not provided. The patient received an unspecified insulin via humapen savvio red at unknown dose, frequency, route of administration, indication for use and start date. On unspecified date, unknown time after starting humapen savvio red, the patient experienced hyperglycemia despite high dose of insulin, which reportedly required hospitalization, but it was unclear if caused or prolonged an existing hospitalization. The reporting nurse checked the patients therapy and stated the humapen savvio red (lot c926392) was not working as usual, when the button was pressed, it did not feel the thrust was regular. It was reported that the humapen savvio red did not have any visible damage outside, but when the nurse tired to give insulin to the patient, it definitely did not inject trough needle (which they changed, also insulin ampoule). Information regarding corrective treatment, laboratory exams and outcome of event was not provided. It was unknown if treatment with unspecified insulin was continued. It was unknown who operated the device and if the operator was trained. Duration of use of this device model and the reported device were unknown. Status of device was not provided, but its return was expected. The reporting nurse was not sure if hyperglycemia was related to the humapen savvio red. Edit 26 may 2021: no new information added. Edit 08 jun 2021: upon internal review on 08 jun 2021, it was noticed the device had been identified as humapen savvio red, therefore device was updated from unknown color to red.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHUMAPEN SAVVIO 3ML (RED)
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key11966365
MDR Text Key267444040
Report Number1819470-2021-00073
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,foreig
Type of Report Initial,Followup
Report Date 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9694
Device Lot NumberC926392
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/30/2015
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: 06/09/2021 Patient Sequence Number: 1
-
-