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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoglycemia (1912); Sweating (2444); Shaking/Tremors (2515)
Event Date 11/25/2019
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: (b)(4). This solicited case, reported by a consumer via patient support program (psp), concerned an (b)(6) female patient of unknown origin. Medical history included diabetes mellitus, heart problem (pacemaker) and pain in legs. Concomitant medication included metformin hydrochloride for tremor. The patient received human insulin isophane suspension (rdna origin) injections (humulin nph) from cartridges via reusable pen (humapen savvio gray), 18iu to 20iu daily for treatment of diabetes beginning in 2004. On (b)(6) 2019, after starting human insulin isophane suspension therapy, she presented hypoglycemia (blood glucose value equal to 45, units and reference ranges were not provided), she had sweating and she fell down. As corrective action for hypoglycemia, she received orange juice. On an unknown date, her blood glucose value was equal to 18 (no units and reference ranges were not provided). The event of hypoglycemia was considered serious due to its medical significance. Reportedly, the units of human insulin isophane suspension that she administered on that day were 20, but she was not sure whether all of the units were administered to her because the humapen savvio gray that she used would stick ((b)(4)/ lot number 1412v01). On (b)(6) 2019, she presented tremor. As corrective treatment for the tremor, she received metformin hydrochloride in an unknown dosage. Information regarding further corrective treatments and outcome for the events was not provided. Human insulin isophane suspension was ongoing. No follow up would be requested as due to local privacy laws reporter contact details were not retained and treating physician contact details were not provided. The patient was the operator of the humapen savvio gray device and her training status was not provided. The humapen savvio gray device model duration of use and suspect humapen savvio gray duration of use were not provided. The action taken with the suspect humapen savvio gray and its return status was not provided. The reporting consumer did not provide a relatedness assessment for the event of incomplete dose administered human insulin isophane suspension and related it to the humapen savvio gray device issue. The reporting consumer related the remaining events to human insulin isophane suspension and the humapen savvio gray. Update 10-dec-2019: additional information received from the initial reporter via psp on 06-dec-2019. Updated; humapen coding to humapen savvio gray upon received clarification and updated narrative with information. Pc details were added. Update 12dec2019: additional information received on 12dec2019 from global product complaint database. Changed the lot number from d049414 to 1412v01 for product complaint (b)(4) relating to the humapen savvio gray. Corresponding fields and narrative updated accordingly. Edit 16dec2019: 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 Key9476431
MDR Text Key187905266
Report Number1819470-2019-00225
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 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9699
Device Lot Number1412V01
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/31/2014
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: 12/16/2019 Patient Sequence Number: 1
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