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U.S. Department of Health and Human Services

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

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ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (GRAPHITE) FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9698
Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Infusion or Flow Problem (2964); Mechanical Jam (2983)
Patient Problems Hypoglycemia (1912); Coma (2417)
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 solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter via a psp, concerned a (b)(6) (at the time of initial report) male patient of an unknown origin. Medical history and concomitant medication were not provided. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin), via a reusable pen (humapen savvio 3ml, graphite), at an unknown dose and frequency, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2014. On an unknown date in (b)(6) 2021, while on human insulin isophane suspension 70%/human insulin 30% therapy, his humapen savvio (graphite) got impaired, as the injection button did not rotate to release insulin and sometimes he hardly took his doses (pc number: (b)(4), lot number: 1212v07). He was tired and could not walk as he suffered from numbness in his legs all the time. On an unknown date, he cannot go to the pharmacy to receive the humapen due to pain in legs and inability to walk. On an unspecified date, when he postpone taking his human insulin isophane suspension 70%/human insulin 30% therapy dose, due to the reusable pen issue, he suffered from a coma due to a drop in the blood glucose level (results, units nor reference values were not provided). The events of coma and blood glucose decreased were considered to be serious by the company due to their medical significance. Information regarding corrective treatments of the events was not provided. Outcome of the events could not walk and numbness in legs was not resolved and for the remaining events it was unknown. The human insulin isophane suspension 70%/human insulin 30% therapy was continued. The patient was the operator the humapen savvio (graphite) and his training status was not provided. The humapen savvio (graphite) general model duration of use was unknown; but it started on an unknown date in 2015. Information regarding suspect humapen savvio (graphite) duration of use, action taken against it was not provided, whereas it was available for return. The initial reporting consumer assessed the tiredness as related to the diabetes mellitus, assessed the tiredness and the blood glucose decreased were not related to the human insulin isophane suspension 70%/human insulin 30% therapy and did not provide any relatedness assessment between the further events and human insulin isophane suspension 70%/human insulin 30% therapy. The reporting consumer assessed the event of missed dose as related and for the rest of the events as not related to humapen savvio (graphite) not working properly. Update 16-apr-2021: additional information received on (b)(6) 2021 from initial reporter via psp, added one non-serious event pain in legs and updated description as reported of event gait disturbance. Updated narrative with new information. Update 27-apr-2021: additional information was received from the initial reporter via a psp on (b)(6) 2021. This case was upgraded to serious as upon follow-up information a coma and a blood glucose serious events were reported. Added serious events of coma and blood glucose decreased and lab test. Narrative was updated accordingly with the new information. Edit 28apr2021: updated medwatch and (b)(6) fields for expedited device reporting. No new information added. Edit 28-apr-2021: upon internal review of the follow-up information received on 21-apr-2021, the causality as reported result from the serious event and the humapen savvio reusable device was corrected from not associated to device nhcp.
 
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Brand NameHUMAPEN SAVVIO 3ML (GRAPHITE)
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 Key11748028
MDR Text Key264067898
Report Number1819470-2021-00064
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 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9698
Device Lot Number1212V07
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/31/2012
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: 04/29/2021 Patient Sequence Number: 1
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