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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (GRAY) FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (GRAY) FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9699
Device Problem Infusion or Flow Problem (2964)
Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Hypoglycemia (1912); Inflammation (1932); Coma (2417)
Event Date 12/31/2019
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 consumer via patient support program (psp), concerned a (b)(6) year-old female patient of unknown ethnicity. Medical history included thyroid gland disorders. Concomitant medications included amlodipine besilate / hydrochlorothiazide / olmesartan medoxomil for hypertension, levothyroxine sodium for thyroid gland disorders and other unspecified medication for gastric disorders and gallbladder inflammation. The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) (humalog mix25) via reusable pen (humapen savvio gray) from 30 to 40 international units (iu) in the morning and 15 to 20 iu each evening, subcutaneously, for diabetes mellitus beginning approximately in 2016. In (b)(6) 2019, she was hospitalized due to a diabetic coma from a low blood glucose level (no values, units or reference ranges provided). After her blood glucose level returned to normal and recovered from the events she was discharged. No more details of corrective treatment or laboratory tests done while hospitalized were provided. Additionally, since (b)(6) 2019, she had been experiencing difficulty to inject insulin with her humapen savvio, the injection button sometimes got stuck and she was not sure if she was taking the right dose, and since then, her blood glucose levels were in the range of 400 mg/dl (product complaint (b)(4)/lot number 1308v07). On unspecified dates, she began to experience gastric disorders, gallbladder inflammation and, she experienced hypertension for a year but it was controlled. The outcome of remaining event was not resolved. Insulin lispro protamine suspension 75%/ insulin lispro 25% therapy status was ongoing. The patient was the operator of the device, but her training status was not provided. The general model duration of use was approximately of four years, but the suspect device model duration of use was unknown. Information regarding improper use of the device, improper storage, device status or action taken was not provided. The reporting consumer assessed the events as not related to insulin lispro protamine suspension 75%/ insulin lispro 25% therapy, but assessed the events wrong dose, blood glucose increased and diabetic coma as related to the device. Also, she assessed the event gastric disorder to taking a lot of unspecified medications. Edit 25feb2020: updated medwatch fields for expedited device reporting. No new information added. Edit 06mar2020: added product complaint number to narrative for expedited device reporting. No new information added.
 
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Brand NameHUMAPEN SAVVIO 3ML (GRAY)
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
640 south rockford drive
tempe AZ 85281
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key9799426
MDR Text Key188252433
Report Number1819470-2020-00020
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 03/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9699
Device Lot Number1308V07
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2013
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: 03/06/2020 Patient Sequence Number: 1
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