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

Model Number MS9699

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

New updated and corrected information is referenced within the update statements in describe event or problem.No further follow up is planned.Evaluation summary: a female patient that her humapen savvio device was not working properly and she was unable to inject insulin.The patient experienced hyperglycemia.The device was not returned to the manufacturer for investigation (batch 1402v07, manufactured february 2014).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of the batch did not identify any atypical findings with respect to device not working issues.All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.There is no evidence of improper use or storage.

Event Description

(b)(4).This spontaneous case, reported by a pharmacist who contacted the company to report an adverse event, concerned a (b)(6) female patient of unknown ethnicity.Medical history and concomitant medications were not provided.The patient received an unspecified insulin via humapen savio (a reusable pen device), beginning on unknown date.Dosing regimen, indication and route of administration were not provided.On an unknown date, while using the humapen savio, she was unable to inject insulin to herself due to humapen savio pen not working properly; she was hospitalized with hyperglycemia ((b)(4), lot no not provided).She was now out of hospital and she was recovered from hyperglycemia.This was the second or third time he had problem with the humapen savio pen.Information regarding corrective treatment, outcome of drug dose omission, unspecified insulin status and status of humapen savvio device treatment was not provided.The operator of the humapen savio and training status was not provided.The humapen savio model duration of use and suspect humapen savio duration were not reported.The status of the humapen savio was not reported and its return was not provided.The reporting pharmacist related the events with humapen savio device.Edit 21mar2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 22-mar-2018: upon review, added pc number to the case and narrative.Update 22mar2018: additional information received on 22mar20187 from global product complaint database.Reiterated the suspect as humapen savvio unknown color as suspect device type as the suspect device was not returned to the manufacturer.Changed the lot number from unknown to c433694 (as reported) for (b)(4) relating to the humapen savvio (unknown color).Corresponding fields and narrative updated accordingly.Update 22mar2018: additional information received on 22mar2018 from global product complaint database.Recoded the suspect humapen savvio unknown color to a humapen savvio gray.Changed the lot number from c433694 to 1402v07 for product complaint 4300716 relating to the humapen savvio gray.Corresponding fields and narrative updated accordingly.Update 30mar2018: additional information received on 29mar2018 from the global product complaint database.Entered device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields; and added the date of manufacturer for the suspect device associated with (b)(4).Corresponding fields and narrative updated accordingly.

• 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
• Manufacturer (Section G): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 7422779
• MDR Text Key: 105263799
• Report Number: 1819470-2018-00043
• 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
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9699
• Device Lot Number: 1402V07
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2014
• 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 Outcome(s): Hospitalization
• Patient Age: 73 YR