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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 Disconnection (1171); Loose or Intermittent Connection (1371); Inaccurate Delivery (2339)
Patient Problems Hyperglycemia (1905); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/31/2020
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred. A follow-up report will be submitted when the final evaluation is completed as necessary.
 
Event Description
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint concerned a (b)(6) years-old (at the time of initial report) male patient of unknown origin. Medical history included diabetes mellitus diagnosed in 2002. Concomitant medications included human insulin, metformin, insulin detemir and dulaglutide all for an unknown indication. The patient received insulin lispro (rdna origin) (humalog 100u/ml) from cartridge formulation, subcutaneously, through a reusable device humapen savvio (graphite), for treatment of dm2 (type ii diabetes mellitus), beginning approximately in 2016 or 2017 (as reported 4-5 years ago). Dosage regimen was not provided. In (b)(6) 2020, after starting insulin lispro, his diabetes got aggravated, he had problems in eyes due to this, he had blood in eyes and he was hospitalized due to this blood in eye and diabetes aggravated. A surgery was performed and without wearing glasses, his vision was only 30%. The event of vision only 30 percent was considered serious due to its medical significance. On an unknown date, because the cartridge holder of his humapen savvio was loose and when inserting a new cartridge it falls off. The humapen savvio still released insulin but he was afraid of using it because he was unsure if it releases the correct dosage (pc number (b)(4) , lot number 1702v03). Outcome of events blood in eye and diabetes got aggravated were resolved while outcome of remaining event was unknown. Further information regarding corrective treatment and outcome of remaining event unknown. Therapy status of insulin lispro was not provided. The user of the humapen savvio was patient and his training status was not provided. The general humapen savvio model duration of use was unknown and suspect humapen savvio duration of use was approximately 15 months. The action taken with the suspect humapen savvio was not provided and its return was not expected. The reporting consumer did not relate the events blood in eye and diabetes got aggravated with insulin lispro treatment and did not provide relatedness of remaining event with insulin lispro. Reporting consumer did not provide relatedness of events with suspect humapen savvio. Edit 04-feb-2021: upon review of the information received on 21-jan-2021, corrected the partial onset date of event diabetes mellitus aggravation. Edit 04feb2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting. No new information added.
 
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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 Key11278772
MDR Text Key233752623
Report Number1819470-2021-00023
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 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9698
Device Lot Number1702V03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2017
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: 02/04/2021 Patient Sequence Number: 1
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