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

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.

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.Update 02jul2021: additional information received on 02jul2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, improper use and storage from no to yes for pc 5531342 associated to lot 1702v04 of humapen savvio (gray) device.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

B.5.Narrative field: new, updated, and corrected information is referenced within the update statements in b.5.Please refer to update statement(s) dated 02jul2021 in the b.5.Field.No further follow-up is planned.Evaluation summary.A female patient reported that her humapen savvio device "does not hold the units; it is completely loose." no adverse event was reported.Initial screening of the device associated the case with the reportable malfunction "clicker clip/sleeve engagement failure." investigation of the returned device (batch 1702v04, february 2017) determined this case was not associated with this reportable malfunction.The investigation found the device could not be dialed up or down due to the dial subassembly spinning freely within the barrel, and the device could not be dosed.The investigation identified the reportable malfunction of a broken bulkhead component and found an oily substance present on the housing collar near the bulkhead subassembly.Spectroscopic analysis of the oily substance identified it to be consistent with a fatty acid-based substance.The fatty acid-based substance, introduced in the field and not related to the manufacturing process, caused degradation of the bulkhead component, causing the device malfunction.Malfunction confirmed.A broken bulkhead can lead to an over- or underdose.The core user manual provides instructions for proper care and storage of the device.It states, "do not use alcohol, hydrogen peroxide or bleach on the pen body or dose window.Also, do not cover in liquid or apply lubrication such as oil, as this could damage the pen." there is evidence of improper use.Foreign material contamination of the device occurred while in the field (not related to the manufacturing process).This misuse is relevant to the finding of bulkhead failure.

• Brand Name: HUMAPEN SAVVIO 3ML (GRAY)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 11923278
• MDR Text Key: 268077107
• Report Number: 1819470-2021-00070
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9699
• Device Lot Number: 1702V04
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/07/2021
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1