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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 Material Separation (1562)
Patient Problems Hyperglycemia (1905); Underdose (2542)
Event Date 10/03/2019
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 compliant: pending. This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient of unknown origin. Medical history included diabetes mellitus, undergone a vertebral column surgery, for vertebrae number 4 and 5. Concomitant medications included glimepiride and metformin hydrochloride for diabetes mellitus, captopril/hydrochlorothiazide for hypertension, benfotiamine/cyanocobalamin/pyridoxine hydrochloride for neuro-strengthening, unspecified vitamins for bone strengthening and unspecified analgesics for bone ache. The patient received insulin lispro (rdna origin) (humalog, 100 u/ml) via a prefilled kwikpen, 60 u morning and 40 u at night, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date approximately in 2014 (five years ago). Approximately in 2017 (1. 5 to 2 years ago) the treating physician advised to replace kwikpen by humapen savvio (gray). Since an unknown date in 2019 (few months ago), he was diagnosed with a cartilage slip in one of the neck vertebrae, which lead to symptoms as arm numbness, loss of sensation, and body tingles. He was scheduled to undergo a neck surgery after an orthopedic consult. The event of cartilage slip in neck vertebrae and loss of sensation were considered as serious by company due to their medically significance. Approximately on (b)(6) 2019, the humapen savvio (gray) injection button had been separated from the pen, leading to inability to use the pen and he had missed all of the week doses (pc# unknown, lot# 1311v55), and the blood glucose level went to a high level, around 650 mg/dl. The event of blood glucose increased was considered as serious by company due to its medically significance. Information regarding corrective treatment was not provided. Outcome of the events was not recovered. Status of insulin lispro therapy was ongoing. The operator of the reusable humapen savvio (gray) device and his/her training status was not provided. The general reusable humapen savvio (gray) device model duration of use and suspect reusable device duration of use was approximately two years (started in 2017). The action taken with status of suspect reusable humapen savvio (gray) device was unknown. The status of suspect reusable humapen savvio (gray) device was ongoing and the return of suspect reusable humapen savvio (gray) device was expected. The initial reporting consumer did not consider the events of missed dose and blood glucose increased related to insulin lispro drug but considered them related to humapen savvio (gray) device. The initial reporting consumer did not consider the reaming events related to insulin lispro drug and humapen savvio (gray) device. Edit 17-oct-2019: upon review of the initial information, changed one mention of the device in narrative from humapen ergo ii to humapen savvio (gray). No new information was added to the case. Edit 22oct2019: updated medwatch fields 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 Key9261309
MDR Text Key184499758
Report Number1819470-2019-00193
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 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9699
Device Lot Number1311V05
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/31/2019 Patient Sequence Number: 1
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