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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 Problems Fluid Leak (1250); Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182)
Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)
Event Date 04/30/2021
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 spontaneous case, reported by a consumer with a product complaint, concerns a female patient of unknown age and origin. Medical history of patient included diabetes since eight years old. Concomitant medication was not provided. The patient received insulin human nph (rdna origin), via a humapen savvio gray (lot number 1411v02), at unknown dose, frequency, route of administration, indication for use and start date. On (b)(6) 2021, unknown time after starting insulin human nph therapy, the patient was hospitalized due to high blood glucose rate, the blood went into acidosis. As reported, the fact might had occurred because the humapen savvio gray was not applying correctly, since all the medication was leaking (product complaint number (b)(4)). The patient was discharged on (b)(6) 2021. It was mentioned patient reused needles at least once, but storage was correct. Corrective treatments and examinations performed, if any, were not provided. The events outcome were unknown, also if there were any changes in insulin human nph therapy. It was unknown who operated the device and if this person was trained. Humapen savvio gray device model had been used for unknown period and the specific reported device (lot 1411v02) had been used for approximately two years. The status of the device was unknown. The return status of the device was not provided. Reporting consumer did not provide any opinion of relatedness between the events and insulin human nph via humapen savvio gray therapy. This case is cross-referenced with cases (b)(4) (same patient). Update 06may2021: additional information received on 03may2021 was processed within initial case entry. Edit 13may2021: updated medwatch fields for expedited device reporting. No new information added. Edit 13may2021: upon review on 13may2021, eu/(b)(6) fields were completed accordingly. Edit 19may2021: 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)
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 Key11849248
MDR Text Key266464250
Report Number1819470-2021-00069
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 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9699
Device Lot Number1411V02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2014
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: 05/19/2021 Patient Sequence Number: 1
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