• 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 Crack (1135); Defective Device (2588)
Patient Problems Hyperglycemia (1905); Anxiety (2328); Diabetic Ketoacidosis (2364); Confusion/ Disorientation (2553); Lethargy (2560)
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. This report is associated with 1819470-2018-00161 since there is more than one device implicated.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a female patient of unknown age and ethnicity. Medical history included type i diabetes. Historical drugs included insulin lispro kwikpen. Concomitant medications were not reported. The patient received insulin lispro (rdna origin) injections, (humalog) cartridge through a reusable humapen savvio (red) device, beginning in (b)(6) 2018; dosage regimen, route of indication and indication for use were not provided. On (b)(6) 2018, after starting insulin lispro treatment, the mechanism inside the pen responsible for pushing the red rubber part to administer insulin according to the dialed dosage, was stuck inside the pen, subsequently not administering insulin and her blood sugar levels were at 21 mmol/l. She was able to rectify her blood sugar level within two hours after insulin dosage correction. On (b)(6) 2018, she again tested her blood sugar and two different measuring apparatus showed high readings (no values provided). She inspected her two humapen savvio and this had similar faults (devices not working), cartridges were cracked ((b)(4)/lot c815599a) ((b)(4)/lot 1703v02) ((b)(4)/lot 1403v01). She also felt lethargic and had to take a nap, began to feel stress, disoriented, agitated and panicked as of the high sugar. She was taken to the hospital, where it was tried to bring down and stabilize her blood sugar but kept on presenting two plus ketones in urine and was transferred to high care ward. She was treated for diabetic ketoacidosis (dka) for three nights in hospital. Information regarding corrective treatment was not reported. Outcome of the first blood sugar event was resolved and it was not reported for remaining events. Insulin lispro treatment status was not reported. The user of the humapen savvio red devices was the patient and her training status was not provided. The humapen savvio red model duration of use along with the suspect device age for the devices was about one month. The suspect humapen savvio red devices associated with product complaints 4454709 4454705 were returned to the manufacturer on 21aug2018. The reporting consumer related the events to insulin lispro and her two humapen savvio red devices. Update 28-aug-2018: additional information received on 16-aug-2018 from the affiliate. Added two new suspect humapen savvio (red) devices and processed pcs accordingly. Narrative and fields were updated accordingly. Update 28aug2018: additional information received on 22aug2018 from global product complaint database. Reiterated suspect humapen savvio device (red), already present and correct in case. Changed the lot number form 1703v04 to 1703v02 for (b)(4) relating to the humapen savvio device (red). Updated device return status to returned to manufacturer and added date returned to manufacturer for the suspect humapen savvio devices associated with (b)(4). Corresponding fields and narrative updated accordingly. Upon review, the suspect device age field was addressed. Edit 04sep2018: 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 SAVVIO 3ML (RED)
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
TECH GROUP NORTH AMERICA INC. DBA WEST
medical device manufacturing
640 south rockford drive
tempe AZ 85281
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key7856275
MDR Text Key119646637
Report Number1819470-2018-00160
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 10/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9694
Device Lot Number1703V02
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/21/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2017
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: 09/07/2018 Patient Sequence Number: 1
-
-