• 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 Failure to Deliver (2338); Mechanical Jam (2983); Output Problem (3005)
Patient Problem Loss of consciousness (2418)
Event Date 04/27/2021
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
(b)(4). This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint (pc), concerned an (b)(6)-year-old female patient of an unknown ethnicity. Medical history included being diabetic since 1991. Concomitant medications were not provided. The patient received human insulin (rdna origin) injections (humulin), from cartridge via a reusable device humapen savvio red, at an unknown dose and frequency via an unknown route for the treatment of an unknown indication, beginning on an unknown date. On (b)(6) 2021, while on human insulin therapy, humapen savvio did not work. The dial turned but the spring inside did not move, and no insulin came out. She tried changing the cartridge and needle and priming but it did not work. She was almost unconscious at this stage. Her family member managed to get insulin from the chemist next door and inject her mother (batch number: 1404v07 and pc number: (b)(4)). The event altered level of consciousness was considered as serious due to medical significance reason. Information regarding corrective treatment, outcome of the event and status of human insulin therapy was not provided. The daughter of the patient was the operator of humapen savvio red and her training status was not provided. The general humapen savvio red duration and suspect humapen savvio red duration was not provided. Action taken with humapen savvio red was not provided and its return was expected. The initial reporting consumer did not provide the relatedness assessment of the event with human insulin therapy while considered it related to humapen savvio red device issue. Edit 06may2021: 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 (RED)
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
PHILLIPS-MEDISIZE CORPORATION
415 red cedar street
medical device manufacturing
menomonie WI 54751
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key11784276
MDR Text Key249456625
Report Number1819470-2021-00068
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 consumer,foreign
Type of Report Initial,Followup
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9694
Device Lot Number1404V07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2014
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: 05/06/2021 Patient Sequence Number: 1
-
-