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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 Loose or Intermittent Connection (1371); Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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 device case, which does not involve an adverse event, reported by a pharmacist, who contacted the company with a product complaint (pc), concerns a female patient of which age and ethnicity were not provided. The patient was taking human insulin isophane suspension 70%/human regular insulin 30% (humulin 70/30) (reported as humulin m3) via a humapen savvio (gray) device for the treatment of an unknown indication since an unknown date. On an unknown date, the patient stated the pen does not hold the units and that it was completely loose (product complaint (b)(4), lot number 1702v04). The operator of device and training status was not provided. The model duration of use was not provided but the suspect device was reportedly used for several years. The suspect humapen savvio (gray) device associated with product complaint (b)(4) was returned to the manufacturer on 07apr2021.
 
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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 Key11923278
MDR Text Key268077107
Report Number1819470-2021-00070
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 foreign,health professional
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9699
Device Lot Number1702V04
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/07/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2021
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

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