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

Model Number MS9694

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Code Available (3191)

Event Type  Injury  

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

(b)(4).This report is associated with product compliant: pending.This spontaneous case, reported by two consumers who contacted the company to report adverse events and a product complaint, concerns a (b)(6) female patient of unknown ethnicity.Medical history and concomitant medications were not provided.The patient received human insulin (rdna origin) nph (humulin n) cartridge, 15 iu every morning and 9 iu every night and also human insulin (rdna origin) regular (humulin r) cartridge at unknown dose and frequency; both insulins were administered via unknown route and for unknown indication beginning on an unspecified date.On an unspecified date, unknown time after beginning human insulin nph and regular therapies via humapen savvio red (lot number 1410v01), the humapen savvio red presented a problem and was not releasing the correct amount of insulin and, due to that, the patient started to fell unwell, her whole body was twisted and her mouth was locked.On an unspecified date in (b)(6) 2017, the patient was hospitalized due to these events.According to reporter, the treating physician stated that the pen was not injecting the amount of insulin that the patient needed.At the time of initial report, on (b)(6) 2017, the patient was already hospitalized for 34 to 36 days and she was still not recovered from reported events.Information regarding laboratorial examinations and corrective treatments was not provided.The humapen savvio red (lot number 1410v01) was associated with product complaint number (b)(4).The status of human insulin nph and regular therapies was not provided.It was unknown who operated the device and if this person was trained.This device model has been used for unknown period of time and the reported humapen savvio red (lot number 1410v01) has been used since (b)(6) 2017.The return status of reported device was not provided.The second reporting consumer related the reported events to the problem of humapen savvio red.No other assessment of relatedness was provided.Update 25apr2017: updated medwatch fields.

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 consumer reported, on the behalf of a female patient, the humapen savvio device was not injecting the amount of insulin the patient needed.Reportedly due to this, the patient was hospitalized with symptoms of feeling unwell, her whole body was twisted, and her mouth was locked.The device was not returned to the manufacturer for investigation (batch 1410v01, manufactured october 2014).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the batch did not identify any atypical findings with respect to dose accuracy or device not working.All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.There is no evidence of improper use or storage.

Event Description

(b)(4).This spontaneous case, reported by two consumers who contacted the company to report adverse events and a product complaint, concerns a (b)(6) female patient of unknown ethnicity.Medical history and concomitant medications were not provided.The patient received human insulin (rdna origin) nph (humulin n) cartridge, 15 iu every morning and 9 iu every night and also human insulin (rdna origin) regular (humulin r) cartridge at unknown dose and frequency; both insulins were administered via unknown route and for unknown indication beginning on an unspecified date.On an unspecified date, unknown time after beginning human insulin nph and regular therapies via humapen savvio red (lot number 1410v01), the humapen savvio red presented a problem and was not releasing the correct amount of insulin and, due to that, the patient started to fell unwell, her whole body was twisted and her mouth was locked.On an unspecified date in (b)(6) 2017, the patient was hospitalized due to these events.According to reporter, the treating physician stated that the pen was not injecting the amount of insulin that the patient needed.At the time of initial report, on (b)(6) 2017, the patient was already hospitalized for 34 to 36 days and she was still not recovered from reported events.Information regarding laboratorial examinations and corrective treatments was not provided.The humapen savvio red (lot number 1410v01) was associated with product complaint (b)(4).The status of human insulin nph and regular therapies was not provided.It was unknown who operated the device and if this person was trained.The reported humapen savvio red (lot number 1410v01) has been used since (b)(6) 2017 approximately three months.The device was discarded; therefore it will not be returned.The second reporting consumer related the reported events to the problem of humapen savvio red.No other assessment of relatedness was provided.Update 25apr2017: updated medwatch fields.Update 22may2017: additional information was received on 18may2017.Updated device return status.Narrative was updated accordingly.Upon internal review, updated eu/ca fields.Update 23may2017: additional information received on 22may2017 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.Added date of manufacturer.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN SAVVIO 3ML (RED)
• 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: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 6525726
• MDR Text Key: 73818833
• Report Number: 1819470-2017-00077
• 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: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9694
• Device Lot Number: 1410V01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2014
• 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
• Treatment: HUMAN INSULIN REGULAR
• Patient Outcome(s): Hospitalization
• Patient Age: 6 YR