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

Model Number MS9696

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

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 patient of unknown gender, age, and ethnicity.The patient was taking an unspecified medication via humapen savvio pen (green); indication for use not provided, on an unknown date.On an unspecified date, it was noted that the dosing knob was blocked.This humapen savvio device was associated with (b)(4)/lot number 1211v05.The operator and training status of the device was not provided.The general model duration of use and duration of use for the suspect device were unknown.The device was returned to the manufacturer on 21mar2018.

Event Description

Lilly case id: (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 patient of unknown gender, age, and ethnicity.The patient was taking an unspecified medication via humapen savvio pen (green); indication for use not provided, on an unknown date.On an unspecified date, it was noted that the dosing knob was blocked.This humapen savvio device was associated with product complaint (b)(4)/lot number 1211v05.The operator and training status of the device was not provided.The general model duration of use and duration of use for the suspect device were unknown.The humapen savvio pen (green) device associated with product complaint (b)(4) was returned to the manufacturer on 21mar2018.Update 20apr2018: additional information was received from the global product complaint database on 20apr2018.As a device specific safety summary was not provided by gps, the malfunction and malfunction type were not updated to no at this time.Corresponding fields and narrative updated accordingly.Update 23apr2018: additional information received on 23apr2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information, improper use and storage from no to yes, and malfunction from yes/cirm to no.Added date of manufacturer for the returned suspect humapen savvio (green) associated with product complaint (b)(4).Corresponding fields and narrative updated accordingly.Update 07may2018: additional information received on from the global product complaint database reiterated trackwise details for suspect device.No new information was added.

Manufacturer Narrative

Narrative field: new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 23-apr-2018.No further follow-up is planned.This is a downgrade report, which no longer meets the criteria for expedited reporting.Evaluation summary: a patient reported that the dosing knob of a humapen savvio device was blocked.Initial screening of the device associated the case with the reportable malfunction "clicker clip/sleeve engagement failure." investigation of the returned device (batch 1211v05, november 2012) determined that this case was not associated with this reportable malfunction, but did find internal damage and foreign material on multiple internal components of the device which caused difficulty in dialing a dose.The type of damage observed is consistent with excessive force applied while dialing the pen.This field damage is not considered to be a reportable malfunction.All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The core user manual instructs to not use the device if it appears broken or damaged and to contact lilly or your healthcare professional for a replacement pen.The user manual also provides care and storage directions.There is evidence of improper use or storage.The user applied excessive force which caused damage to the device.Foreign material contamination of the device occurred while in the field (not related to the manufacturing process).

• 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
• MDR Report Key: 7430197
• MDR Text Key: 105921599
• Report Number: 1819470-2018-00051
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9696
• Device Lot Number: 1211V05
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1