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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 Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017)
Patient Problem Hypoglycemia (1912)
Event Date 10/09/2019
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 spontaneous case, reported by a consumer who contacted the company to report a product complaint (pc) and adverse events, with additional information from the initial reporter via quality department, concerned an (b)(6)-year-old male patient of unknown ethnicity. Medical history included being a type ii diabetic since age (b)(6) (around 1975). Concomitant medications were not reported, however, he was polymedicated. The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin m3, 100u/ml) from cartridges via a reusable pen (humapen savvio graphite) beginning on an unknown date (as reported, many years ago); indication for use, dosage regimen and route of administration were not provided. Since an unknown date while on human insulin isophane suspension 70%/ human insulin 30% therapy, he had problems with the use of insulin pens (unspecified), for instance, his humapen savvio graphite was not working properly, it was thought that it was delivering too much insulin (associated (b)(4)/ lot number: 1612v01). He did not have problems when he administered the medication while being accompanied, but all the situations when he was unable to administer it were at times when he was alone. Reportedly, since an unspecified date he had some vision difficulties and for this reasons his family wanted to understand if it was a problem with the humapen savvio graphite or a misuse of the same from the patient. He had been experiencing different hypoglycemia episodes lately (no data provided). On (b)(6) 2019 at 1 am, he had a severe hypoglycemia reaching glucose levels of 30 mg/dl (no reference range provided). It took an hour and a half to recover. Then, on (b)(6) 2019 at 5 am, he was shaking a lot, and it was thought it was a panic attack. On (b)(6) 2019, he was admitted to the hospital. Hospitalization details including laboratory examination findings and corrective measures were not provided. As of (b)(6) 2019 he was still hospitalized. Corrective treatment, outcome of the remaining events and status of human insulin isophane suspension 70%/ human insulin 30% were not provided. The patient was the user of the humapen savvio graphite and his training status was not provided. The general humapen savvio graphite model duration of use and suspect humapen savvio graphite duration of use were not provided; however, it was reported that suspect humapen savvio graphite was too old. The patient had vision difficulties. Action taken with suspect humapen savvio graphite was not reported and its return was anticipated. The reporting consumer did not provide an assessment of relatedness between the events and human insulin isophane suspension 70%/ human insulin 30% therapy and related the incorrect dose administered, resulting hypoglycemia, and possible missed dose to problems with the humapen savvio graphite. The reporting consumer did not provide an assessment of relatedness between the remaining events and the humapen savvio graphite. Update 15-oct-2019: initial information received on 11-oct-2019 from the initial reporter and additional information received from the initial reporter by the quality department on 11-oct-2019 was processed at the same time. Edit 24oct2019: updated medwatch fields for expedited device reporting. No new information added. Update 24-oct-2019: additional information received on 17-oct-2019 from the initial reporter by the quality department. Added the non-serious event of visual impairment. Improper use was updated to yes. Updated hospitalization duration details and narrative with the new information.
 
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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)
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 Key9261308
MDR Text Key183998685
Report Number1819470-2019-00195
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 01/08/2020
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
Device Model NumberMS9698
Device Lot Number1612V01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/31/2016
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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