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

Model Number MS9696

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

(b)(4).This device case, which does not include an adverse event, reported by a consumer who contacted the company with a product complaint, concerns a male patient of unknown age and ethnicity.The patient was taking an unspecified medication for treatment of an unknown indication.On unknown date, the humapen savvio green did not work.This humapen savvio green was associated with product complaint (b)(4)/ lot number 1504v01.It was unknown who operated the device and if the operator was trained.The duration of use for the device model and for the suspect device was not reported.The humapen savvio green was returned to the manufacturer on 31may2022.Edit 21jun2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

Manufacturer Narrative

Reportable malfunction/incident identified.Investigation in progress.A follow-up report will be submitted when the final evaluation is completed as necessary.

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 13jul2022 in the b.5.Field.No further follow-up is planned.Evaluation summary.A male patient reported that his humapen savvio device did not work.No adverse event was reported.Initial screening of the device associated the case with the reportable malfunction "bulkhead failure." investigation of the returned device (batch 1504v01, manufactured april 2015) determined that this case was not associated with this reportable malfunction.The bulkhead subassembly was intact and undamaged.The investigation found the device was inoperable due to internal damage to multiple internal components of the device, including the dial nut housing, dialing screw, sleeve, and bulkhead keys.The type of damage observed is consistent with excessive torque applied while dialing the pen.In addition, the dose numbers were observed to be faded due to chemical exposure while in the field.The damage to the device would have been discovered during the end of line visual inspection and testing process for proper dialing capabilities.The instructions for use state clearly not to use the pen if any of the parts appear broken or damaged and to always carry a spare insulin pen in case your pen is lost or damaged.The core user manual also provides adequate care and storage directions and states to not use alcohol, hydrogen peroxide or bleach on the pen body or dose window, and to not cover in liquid or apply lubrication such as oil, as this could damage the pen.There is evidence of improper use.The damage to the device occurred while in the field (not related to the manufacturing process).This misuse is relevant to the complaint.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This device case, which does not include an adverse event, reported by a consumer who contacted the company with a product complaint, concerns a male patient of unknown age and ethnicity.The patient was taking an unspecified medication for treatment of an unknown indication.On unknown date, the humapen savvio green did not work.This humapen savvio green was associated with product complaint 5992845/ lot number 1504v01.It was unknown who operated the device and if the operator was trained.The duration of use for the device model and for the suspect device was not reported.The humapen savvio green was returned to the manufacturer on 31may2022.Edit 21jun2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 14jul2022: additional information received on 11jul2022 and 13jul2022 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information for (b)(4) associated with lot number 1504v01 of humapen savvio green.Updated malfunction from yes/cirm to yes/not cirm , improper use and storage from no to yes, date of manufacturer.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN SAVVIO 3ML (GREEN)
• Type of Device: FOR 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 Key: 14755987
• MDR Text Key: 302399528
• Report Number: 1819470-2022-00049
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9696
• Device Lot Number: 1504V01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/31/2022
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male